Aug 05 2020

New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

 

By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS

 

 Special Interest Guidances/Information Date Posted
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020
Multiple Function Device Products: Policy and Considerations – Final Guidance 29 Jul 2020
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval – Final Guidance (Revision 1) 29 Jul 2020
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format – Draft Guidance (Revision 1) 29 Jul 2020
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products – Final Guidance 29 Jul 2020
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products – Draft Guidance 28 Jul 2020
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:  Minimal Manipulation and Homologous Use – Final Guidance 21 Jul 2020
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research – Draft Guidance 21 Jul 2020
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency – Final Guidance 20 Jul 2020
Clinical Investigations for Prostate Tissue Ablation Devices – Final Guidance 15 Jul 2020
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act – Final Guidance 15 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Brain Metastases – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients – Final Guidance 10 Jul 2020
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking – Final Guidance 01 Jul 2020

 

Upcoming Meetings (* = New)
* Sep 08-09, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
* Aug 18-19, 2020: Science Advisory Board to the National Center for Toxicological Research 2020 Meeting
* Aug 13, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting

Last updated: 04 August 2020

Jul 20 2020

Are you ready for the new European clinical trial regulation?

29 June 2020 – Cleo François MSc, Regulatory Affairs Manager

Are you ready for the new European clinical trial regulation?

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directivethe directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is favourable for conducting clinical trials, and to encourage more sponsors to conduct trials across the European Union (EU) member states. The regulation will have a major impact on the conduct of clinical trials.

The Regulation will include:

  • More harmonized and efficient clinical trial application procedures;
  • Increased transparency regarding clinical trial data;
  • Provisions that should be considered by sponsors to enhance safety and efficacy of drugs.

The implementation of 2001/20/EC Directive was an important step towards the harmonization of clinical trials in Europe, but as it was still subject to individual member state interpretations there were discrepancies in the laws between countries. This resulted in higher costs for sponsors and long trial start-up timelines. The number of newly registered clinical trials per year in Europe is declining in the past decade. The new ECTR aims to create a uniform framework for electronic clinical trial authorization and a centralized assessment of the application dossier. This will result in reducing duplication of effort and costs. It will also likely lead to improved collaboration, information-sharing, and decision-making between and within EU member states.

The new ECTR No. 536/2014 was released back in 2014 – yet the industry still awaits its full implementation. The ECTR will become effective after the EU web portal and database have been set up. The significant technical complications in the portal and database have delayed the effective date of the new regulation. The completion of a fully functional database will be confirmed by an independent audit that will start in December 2020. Currently, it is expected that the portal and database will go live in December 2021.

The new regulation is applicable for Investigational Medicinal Products (IMPs) for human use and does not apply to non-interventional trials or trials without medicinal products (e.g. devices or surgery). Clinical trials that started before the effective date of the regulation can continue complying with the Directive for three years. After this transition period, all clinical trials should be conducted according to the ECTR.

Key changes in the regulation:

Legislative – The Directive set out a number of requirements for member states to achieve individually through changes in their own national legislations. This resulted in many discrepancies between countries, which will be reduced by the new Regulation.

EU Clinical Trial Portal and Database – A single, unified portal and database for sponsors, health authorities, and ethics committees of all members states will be implemented. The EU portal will be the central platform for sponsors to submit applications and notifications, and is built to allow a one-time submission across the multiple European countries. The regulators can perform their assessments and supervise the trial via the portal, which needs to be used for all related sponsor-regulator communication. The system will be accessible via individual workspaces for sponsors, regulatory authorities and the public. The system will contain collaboration tools, as well as workflow and document management capabilities.

Simplified submission process – The submission of research protocols and other study-related documents will be performed centrally and digitally by all selected member states. The application dossiers will be divided in 2 parts:

  • The assessment of Part 1 includes medical sciences and product rating;
  • The assessment of Part 2 concerns national matters (e.g. information letter for subjects, insurance and privacy aspects).

The timelines for assessments of Part 1 and Part 2 are the same in all member states. In multinational trials, the participating member states will jointly assess Part 1. For each study proposal, one member state is the so-called reporting member state, with the role of providing a summary opinion on Part 1 from all member states, following consultation with the review committee of the other participating member states. The report on Part 1 is applicable to all member states. The assessment of Part 2 will be performed by each member state separately. Based on the selected submission strategy, Part 1 and Part 2 assessments will be performed in parallel or in succession.

The regulation provides defined timelines for the different stages of the authorization process. The review of Part 1 will take maximum 45 calendar days. In case of queries, this timeline will be extended with 31 calendar days. A deadline of only 12 calendar days will be given to the sponsor to answer queries.

Transparency – Study information in the EU database will be publicly accessible, thus increasing transparency. Additionally, the sponsor will be required to publish 2 summary reports within 1 year after trial end: a scientific summary report and a summary report in layman’s language. Personal information that could be used to identify participants or commercially sensitive information will not become public.

How CATO SMS is preparing for the change

The ECTR will have a major impact on the conduct of clinical trials, especially on timelines for trial start-up and milestones (e.g. first-patient-first-visit). For this reason, sponsors will have to prepare when planning a new clinical trial, by taking the 3-year transition time into consideration. In preparation for the ECTR implementation, several guidance documents have been published.

Proactively considering the available guidance documents, the regulatory affairs team at CATO SMS is setting-up the implementation and procedural updates accordingly. During the set-up of new clinical trials according to ECTR, CATO SMS will guide sponsors and provide updated submission strategies in line with the new guidelines and the compressed timelines, crucial for consideration in the planning of new clinical trials. Support in the transition of ongoing trials started under the Directive but requirements to meet the ECTR specifications will also be provided. Lastly, CATO SMS is also well equipped to support writing of the clinical trial summary in line with the ECTR specifications.

Want to learn more?

Interested what will be the best submission strategy for your clinical trial? Want to learn more about what CATO SMS can do for you? Contact our business development team for more information.

Jul 05 2020

New FDA Gudiances for June 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS

 

 Special Interest Guidances/Information Date Posted
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30 Jun 2020
Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry – Final Guidance 29 Jun 2020
Development of Anti-Infective Drug Products for the Pediatric Population : Draft Guidance for Industry – Draft Guidance 29 Jun 2020
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 22 Jun 2020
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry – Final Guidance 19 Jun 2020
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 19 Jun 2020
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry – Final Guidance 16 Jun 2020
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 08 Jun 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 05 Jun 2020
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 04 Jun 2020
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators: Guidance for IRBs and Clinical Investigators – Final Guidance 02 Jun 2020
CVM GFI #240 Proprietary Names for New Animal Drugs – Final Guidance 01 Jun 2020

 

Upcoming Meetings (* = New)
* July 14, 2020: Meeting of the Oncologic Drugs Advisory Committee
* Aug 19-19, 2020: Science Advisory Board to the National Center for Toxicological Research 2020 Meeting

 

Last updated: 01 July 2020

Jun 08 2020

New FDA Gudiances for May 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS

 

 Special Interest Guidances/Information Date Posted
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) – Final Guidance 28 May 2020
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry – Final Guidance 28 May 2020
Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 27 May 2020
Orange Book Questions and Answers Guidance for Industry: Draft Guidance for Industry – Draft Guidance 27 May 2020
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers – Final Guidance 26 May 2020
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft Guidance for Industry – Draft Guidance 26 May 2020
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 May 2020
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 May 2020
Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry – Final Guidance 22 May 2020
Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines: Guidance for Industry – Final Guidance 22 May 2020
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 May 2020
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry – Final Guidance 19 May 2020
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic: Guidance for Industry – Final Guidance 12 May 2020
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic – Final Guidance 11 May 2020
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry – Final Guidance 11 May 2020
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products : Guidance for Industry and Investigators – Final Guidance 11 May 2020
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff – Final Guidance 11 May 2020
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency – Final Guidance 07 May 2020
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 May 2020
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry – Final Guidance 05 May 2020
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 04 May 2020
Investigational COVID-19 Convalescent Plasma: Guidance for Industry – Final Guidance 01 May 2020

 

Upcoming Meetings (* = New)
  June 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee [POSTPONED]
* June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) [UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION]

Last updated: 05 June 2020

May 07 2020

What’s New Health Canada?

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate

 

What’s New in:

 

Updates from Health Canada

 

New Private Label Medical Device Licence Application Form 07 April 2020
Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device 09 April 2020
Type of Update and Link Date Posted
Guidance Document – Preparation of Regulatory Activities in eCTD Format 14 April 2020
Class II Medical Device Licence Amendment Application Form 15 April 2020
Medical Devices Licence Amendment Fax-Back Form – Guidance for Non-Significant Additions / Deletions 22 April 2020
Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot for Clinical Trials 22 April 2020
Guidance Document on the Distribution of Drugs as Samples 29 April 2020
Medical Devices Licence Amendment Fax-Back Form – Guidance for Changes to the Manufacturer’s Name And / Or Address Of Existing Device Licences Only 30 April 2020
Type of Update and Link Date Posted
COVID-19  
Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 18 Mar 2020
Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 – Guidance Document 26 Mar 2020
COVID-19 health product industry  01 April 2020
Exceptional importation and sale of medical devices against COVID-19  05 April 2020
Exceptional importation and sale of drugs and biocides against COVID-19 05 April 2020
Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 05 April 2020
Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device 09 April 2019
Health Product Advertising Incidents related to COVID-19 16 April 2020
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors 22 April 2020
International Coalition of Medicines Regulatory Authorities (ICMRA) statement on COVID-19 29 April 2020
Engaging with international partners on COVID-19 30 April 2020
Application for a Medical Device Licence Amendment for a Private Label Medical Device 07 April 2020

 

Santé Canada: Quoi de neuf?

 

Par Alejandra Gomez Perez. M.Sc., Associée, Affaires Réglamentaires

 

Quoi de neuf :

 

Mises à jour de Santé Canada

 

Genre de mise à jour et lien Date
Nouvelle demande d’homologation d’un instrument médical de marque privée 07 avril 2020
Ligne directrice : Comment remplir une nouvelle demande d’homologation et une demande de modification d’homologation pour les instruments médicaux de marque privée 09 avril 2020
Ligne directrice – Préparation des activités de réglementation des drogues en format eCTD 14 avril 2020
Formulaire de demande de modification d’homologation d’un instrument médical de classe II 15 avril 2020
Formulaire de modification d’homologation des matériels médicaux à retourner par fax – Instructions concernant uniquement les additions/suppressions non importantes de numéros de catalogue 22 avril 2020
Avis Mise à jour : Projet pilote non fonctionnel relatif au processus d’inscription réglementaire (PIR) pour les essais cliniques 22 avril 2020
Ligne directrice sur la distribution de médicaments sous forme d’échantillons 29 avril 2020
Formulaire de modification d’homologation des matériels médicaux à retourner par télécopieur – Directives sur les modifications du nom et/ou de l’adresse du fabricant pour les homologations existantes seulement 30 avril 2020
COVID-19  
Avis : Examen accéléré des présentations et demandes de produits de santé liées au COVID-19 18 mar 2020
Liste des instruments diagnostiques visant une utilisation contre le coronavirus (COVID-19) 26 mar 2020
Industrie des produits de santé contre la COVID-19 01 avril 2020
Mesures d’exception pour l’importation et la vente d’instruments médicaux contre la COVID-19  05 avril 2020
Importations et ventes exceptionnelles de drogues et de biocides dans le cadre de la COVID-19 05 avril 2020
Arrêté d’urgence concernant les drogues, les instruments médicaux et les aliments à des fins diététiques spéciales dans le cadre de la COVID-19  05 avril 2020
Ligne directrice : Comment remplir une nouvelle demande d’homologation et une demande de modification d’homologation pour les instruments médicaux de marque privée 09 avril 2019
Incidents concernant la publicité de produits de santé liés à la COVID-19 16 avril 2020
La gestion des essais cliniques pendant la pandémie de COVID-19 : Avis aux promoteurs d’essais cliniques 22 avril 2020
International Coalition of Medicines Regulatory Authorities (ICMRA) déclaration sur COVID-19 (en anglais seulement) 29 avril 2020
Collaboration avec des partenaires internationaux au sujet de la COVID-19 30 avril 2020
Nouvelle demande d’homologation d’un instrument médical de marque privée 07 avril 2020

May 01 2020

New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS

 

 Special Interest Guidances/Information Date Posted
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry – Final Guidance 30 April 2020
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry – Final Guidance 29 April 2020
eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 27 April 2020
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff – Final Guidance 24 April 2020
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 23 April 2020
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 23 April 2020
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 22 April 2020
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 22 April 2020
Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 22 April 2020
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 21 April 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry – Final Guidance 20 April 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency – Final Guidance 16 April 2020
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 16 April 2020
CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV – Final Guidance 14 April 2020
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 14 April 2020
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry – Final Guidance 13 April 2020
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 10 April 2020
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry – Final Guidance 09 April 2020
Investigational COVID-19 Convalescent Plasma: Guidance for Industry – Final Guidance 08 April 2020
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 06 April 2020
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 April 2020
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 April 2020
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and FDA Staff – Final Guidance 05 April 2020
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 04 April 2020
CVM GFI #270 – Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency – Final Guidance 03 April 2020
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act – Final Guidance 03 April 2020
Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 03 April 2020
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 02 April 2020
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry – Final Guidance 02 April 2020
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry – Final Guidance 02 April 2020
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for Industry – Final Guidance 02 April 2020
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 02 April 2020
Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 01 April 2020

 

Upcoming Meetings (* = New)
  April 21, 2020: Pulmonary-Allergy Drugs Advisory Committee
  April 23-24, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee [POSTPONED]
  May 8, 2020: Cellular, Tissue and Gene Therapies Advisory Committee
  June 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee [POSTPONED]

Last updated: 01 May 2020

Apr 29 2020

Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

By Ashley Henderson, PhD, CATO SMS Scientist

1.0 INTRODUCTION

The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications may be required and protocol deviations may be unavoidable. FDA initially issued  FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‑19 Public Health Emergency – Guidance for Industry, Investigators, and Institutional Review Boards on 18 March 20 with subsequent updates in late March and mid-April. This guidance outlines considerations to assist sponsors in the conduct of clinical trials during the COVID‑19 pandemic and offers recommendations to manage protocol amendments and deviations and document changes to the conduct of the trial to ensure patient safety, compliance with GCP, and minimize impact on trial integrity.

2.0 CONSIDERATIONS FOR ONGOING CLINICAL TRIALS

During the COVID‑19 pandemic, it is important for sponsors to consider the specific circumstances of each clinical study, including the nature of the investigational product and the disease under study, the ability to conduct appropriate safety monitoring, and possible impacts on the investigational impact of the study. It is critical that trial participants are kept informed of all changes and steps are taken to appropriately document changes through protocol amendments and in the clinical study report.

2.1 Trial Recruitment and Participation: Halt or Continue?

The FDA recognizes that the current crisis is going to disrupt ongoing treatment of trial participants, recruitment of new participants, and participant monitoring. When deciding to continue, modify, or halt a trial, sponsors are encouraged to carefully evaluate the impact on participants and clearly communicate any changes to trial participants. When making this decision, sponsors must consider the risk and benefits to study participants during under the circumstances of the pandemic, the ability to collect meaningful and complete data, the feasibility of any modifications including appropriate documentation and reporting to regulatory authorities, and availability of alternative approaches to adequately monitor subject safety. The safety of clinical trial participants much be central to any decisions regarding trial conduct. At CATO SMS, we can help sponsors navigate these decisions and we believe that many studies can continue, safely and ethically.

2.2 Subjects cannot travel to study site: Bringing the Trial to the Participant.

Regardless of the impact of COVID‑19 on a clinical trial, the safety of trial participants paramount. Due to travel restrictions or risk of COVID‑19 exposure, subjects that are enrolled in trials may not be able to travel to sites for medical assessments. The FDA guidance directs sponsors to consider alternative means to remotely conduct safety evaluations. Maintaining active communication with trial participants is essential and must continue. Virtual visits and decentralized trial activities will demonstrate remarkable value during the pandemic. When considering alternative approaches to safety assessments, sponsors must consider the feasibility and availability of alternative means to effectively conduct appropriate safety assessments. A decentralized research platform such as offered by THREAD (www.THREADresearch.com) can allow trial activities normally conducted in the clinic to move to a remote setting.

THREAD is a leader in providing decentralized study technology platform and services including Virtual Visits. Virtual Visits allow investigators to observe participants, instruct them to complete assessments, and record their observations directly into a Data Capture/eSource form.  The technology required to accomplish greater participant convenience is provided securely, through one unified platform.

2.3 Maintaining access to Investigational Product and Trial Supplies when Access to Study Site is Limited

It is imperative that sponsors conduct ongoing risk evaluations when deciding to continue treatment with investigational product. In many cases, the benefits of treatment outweigh the risks presented by the COVID‑19 crisis. Sponsors should consider whether home delivery of investigational product and other trial supplies is feasible for each study. This decision should include acknowledgement of requirements for shipment and storage of investigational product in addition to the existing regulatory requirements for accountability and distribution of investigational product. Additionally, appropriate documentation of all changes is required.

The FDA recognizes that in some circumstances, including supply chain interruptions or the inability to ensure the safe use of investigational product, it may be necessary to discontinue use of investigational product. In these cases, the sponsor should consider amending the protocol to limit investigational product use to those participants with apparent benefit and discontinue investigational product use to other participants. If a participant discontinues use of investigational product, it is essential that subject communication and appropriate safety monitoring is maintained after discontinuation.

2.4 Site Management and Modifications to Monitoring

The FDA acknowledges that on‑site monitoring visits may not be possible during the current crisis. Sponsors should work to find alternative ways to maintain trial subject safety and ensure trial data quality and integrity such as enhanced central monitoring, telephone contact with sites, or remote monitoring of individual trial participants. While FDA recognizes that delays in on‑site monitoring may result in delayed identification of GCP non‑compliance, it is critical for sponsors and monitors to carefully document all limited access or delayed monitoring situations. Changes in protocol conduct necessary to immediately assure participant safety can be immediately implemented with subsequent review by the IRB and notification to FDA.

In these unprecedented circumstances it is essential that sponsors work to assure the safety of all trial participants and maintain standards of good clinical practice, while minimizing risks to trial integrity. At CATO SMS, we have the technology, experience, and expertise to support and navigate sponsors through the challenges presented by the current global pandemic.

2.5 Impacts to the Study Report

It is expected that all sponsors, investigators, and IRBs/IECs make robust efforts to maintain the safety of trial participants and integrity of trial data and these measures should be clearly documented in the clinical study report. For all trials impacted by the COVID‑19 pandemic, sponsors should describe in the clinical study report (or in a separate study‑specific document) the following information:

  • A description of all contingency measures implemented to manage trial conduct and disruptions as a result of pandemic‑related control measures.
  • A listing of all participants affected by COVID‑19 related disruption by subject identifier and study site, and a description of how the subject’s participation was impacted
  • Analyses and discussions that address the impact of implemented contingency measures on the safety and efficacy results reported for the study

In addition to the above, all changes to a trial as a result of the COVID‑19 pandemic must be clearly documented in the clinical study report. These changes include modified visit schedules, missed visits, or subject discontinuations. FDA acknowledges that these changes will likely lead to missing information. It is important for sponsors to capture specific details in the case report form to explain the reason for the missing information, including the relationship to COVID‑19. If it is not possible for sponsors to capture this information in the case report form, FDA recommends that sponsors develop processes to systematically capture this information across sites in a way that allows appropriate analysis when the data are submitted to FDA. Additionally, FDA suggests sponsors may also develop methods to capture site‑level status, site‑level or vendor‑level protocol deviations, and process deviations.

Apr 06 2020

New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.

 

 Special Interest Guidances/Information Date Posted
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 30 Mar 2020
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 29 Mar 2020
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry: Guidance for Industry – Final Guidance 27 Mar 2020
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 27 Mar 2020
Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency : Guidance for Industry – Final Guidance 26 Mar 2020
Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry – Final Guidance 24 Mar 2020
CVM GFI #269 – Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak – Final Guidance 24 Mar 2020
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry – Final Guidance 24 Mar 2020
CVM GFI #108 Registering with CVM’s Electronic Submission System – Final Guidance 23 Mar 2020
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals – Final Guidance 22 Mar 2020
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 22 Mar 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 20 Mar 2020
Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)  – Final Guidance 19 Mar 2020
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic – Final Guidance 19 Mar 2020
Submission of Plans for Cigarette Packages and Cigarette Advertisements – Final Guidance 19 Mar 2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic : Guidance for Industry, Investigators, and Institutional Review Boards – Final Guidance 18 Mar 2020
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry – Draft Guidance 17 Mar 2020
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide: Guidance for Industry – Final Guidance 17 Mar 2020
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 17 Mar 2020
Competitive Generic Therapies – Final Guidance 16 Mar 2020
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry: Guidance for Industry – Final Guidance 16 Mar 2020
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff – Final Guidance 16 Mar 2020
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency – Final Guidance 14 Mar 2020
Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry – Final Guidance 12 Mar 2020
510(k) Third Party Review Program: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations – Final Guidance 12 Mar 2020
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Draft Guidance for Industry – Draft Guidance 11 Mar 2020
Q3D(R1) ELEMENTAL IMPURITIES – Final Guidance 10 Mar 2020
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry – Draft Guidance 10 Mar 2020
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 09 Mar 2020
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry – Draft Guidance 06 Mar 2020
Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry – Draft Guidance 06 Mar 2020
Safety Testing of Drug Metabolites – Final Guidance 05 Mar 2020
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry – Final Guidance 04 Mar 2020
Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 04 Mar 2020
Bone Anchors – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 03 Mar 2020

 

Upcoming Meetings (* = New)
  April 21, 2020: Pulmonary-Allergy Drugs Advisory Committee
  April 23, 2020: Medical Imaging Drugs Advisory Committee
  April 23-24, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
* May 8, 2020: Cellular, Tissue and Gene Therapies Advisory Committee
* June 9, 2020:  Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Last updated: 06 April 2020

Mar 04 2020

New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

 

 Special Interest Guidances/Information Date Posted
Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff – Final Guidance 29 Feb 2020
CVM GFI #264 Standardized Medicated Feed Assay Limits – Draft Guidance 27 Feb 2020
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Feb 2020
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Feb 2020
Product Labeling for Laparoscopic Power Morcellators: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 26 Feb 2020
CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs – Final Guidance 21 Feb 2020
Guidance for Industry: FDA’s Voluntary Qualified Importer Program – Final Guidance 21 Feb 2020
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry – Final Guidance 21 Feb 2020
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments – Final Guidance 14 Feb 2020
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices – Draft Guidance 13 Feb 2020
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration – Draft Guidance 13 Feb 2020
Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 13 Feb 2020
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry – Draft Guidance 6 Feb 2020
Withdrawn CDER Product Specific Guidances – Final Guidance 5 Feb 2020
Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II): Guidance for Industry – Final Guidance 5 Feb 2020
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy – Draft Guidance 4 Feb 2020
Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels – Final Guidance 3 Feb 2020
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry – Draft Guidance 3 Feb 2020
Chapter 53 – 7353.001c Risk Evaluation and Mitigation Strategies – Final Guidance 1 Feb 2020
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims – Final Guidance 30 Jan 2020

 

Upcoming Meetings (* = New)
  March 4, 2020: Vaccines and Related Biological Products Advisory Committee Meeting
* March 11, 2020: Nonprescription Drugs Advisory Committee
* April 2-3, 2020: Blood Products Advisory Committee
* April 21, 2020: Pulmonary-Allergy Drugs Advisory Committee
* April 23, 2020: Medical Imaging Drugs Advisory Committee
* April 23-24, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
* May 15, 2020: Allergenic Products Advisory Committee

Last updated: 04 March 2020

Mar 04 2020

What’s New Health Canada? January and February 2020 Updates

 

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate

 

What’s New in:

 

 

Updates from Health Canada

 

Type of Update and Link Date Posted
Notice: Product Monograph Implementation Plans 13 January 2020
Notice: Implementation of eCTD for Clinical Trial Regulatory Activities 19 February 2020
Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products 26 February 2020

 

 

Santé Canada: Quoi de neuf?

Par Alejandra Gomez Perez. M.Sc., Associée, Affaires Réglamentaires

 

Quoi de neuf :

 

 

Mises à jour de Santé Canada

 

Genre de mise à jour et lien Date
Avis : Plans de mise en œuvre des monographies de produit 17 février 2020
Avis : Mise en œuvre du format eCTD pour les activités de réglementation des essais cliniques 19 février 2020
Avis : Publication de l’ébauche de la ligne directrice aux fins de consultation : Études pharmacocinétiques comparatives sur les produits administrés par inhalation orale 26 février 2020

Older posts «