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

Feb 04 2020

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

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

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Special Interest Guidances/Information Date Posted
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 28 Jan 2020
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Retinal Disorders: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Rare Diseases: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Hemophilia: Guidance for Industry – Final Guidance 28 Jan 2020
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry – Final Guidance 28 Jan 2020
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry – Final Guidance 28 Jan 2020
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry – Draft Guidance 27 Jan 2020
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry – Final Guidance 24 Jan 2020
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff – Final Guidance 22 Jan 2020
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry – Draft Guidance 22 Jan 2020
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers: Draft Guidance for Industry – Draft Guidance 15 Jan 2020
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 13 Jan 2020
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry – Final Guidance 02 Jan 2020
 
Upcoming Meetings (* = New)
* February 26, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting
* March 4, 2020: Vaccines and Related Biological Products Advisory Committee Meeting

Last updated: 04 February 2020

Jan 06 2020

New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research

Special Interest Guidances/Information

Date Posted

Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance

30 Dec 2019

Submission of Plans for Cigarette Packages and Cigarette Advertisements – Draft Guidance

27 Dec 2019

Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry – Draft Guidance

23 Dec 2019

Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff – Draft Guidance

23 Dec 2019

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry – Draft Guidance

20 Dec 2019

Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

20 Dec 2019

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document – Final Guidance

20 Dec 2019

Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry – Final Guidance

19 Dec 2019

Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry – Draft Guidance

18 Dec 2019

30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff – Final Guidance

16 Dec 2019

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals – Final Guidance

16 Dec 2019

Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff – Final Guidance

16 Dec 2019

Chapter 2 – Biologics – Final Guidance

13 Dec 2019

Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff – Draft Guidance

13 Dec 2019

FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Draft Guidance for Industry – Final Guidance

12 Dec 2019

Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry – Draft Guidance

09 Dec 2019

Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff-Draft Guidance

09 Dec 2019

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry: Draft Guidance for Industry-Draft Guidance

04 Dec 2019

Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry-Final Guidance

29 Nov 2019

Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products-Draft Guidance

27 Nov 2019

Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry-Final Guidance

26 Nov 2019

Certificates of Confidentiality: Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff-Draft Guidance

22 Nov 2019

CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances-Draft Guidance

20 Nov 2019

Transdermal and Topical Delivery Systems – Product Development and Quality Considerations-Draft Guidance

20 Nov 2019

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry-Final Guidance

15 Nov 2019

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff-Final Guidance

14 Nov 2019

 

Upcoming Meetings (* = New)

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January 14, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 01/14/2020 – 01/14/2020

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January 15, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 01/15/2020 – 01/15/2020

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January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 01/16/2020 – 01/16/2020

Last updated: 06 January 2020

Dec 20 2019

What’s New Health Canada? November 2019 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 – Update to Clinical Trial Site Information Form 29 November 2019
Notice – Submitting Master File Transactions via the Common Electronic Submissions Gateway (CEGS) 29 November 2019

 

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 – Mise à jour du formulaire d’information sur le lieu de l’essai clinique 29 novembre 2019
Avis – Soumission de transactions de fiches maîtresses par l’entremise du Portail commun de demandes électroniques (PDCE) 29 novembre 2019

Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research

FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications”.

Instead of the traditional 510(k), manufacturers may choose an alternative approach: to submit an abbreviated 510(k) to demonstrate substantial equivalence in premarket notification for class II medical devices, relying on one or more of the following:

  • FDA guidance document(s)

The use of guidance documents may facilitate the review through a reliance on a summary report that summarize the device description, the manufacturer’s device design, risk management, and a description of test methods used to address performance characteristics as recommended in relevant guidance document(s). The report should include information regarding any deviations or alternative methods used to demonstrate substantial equivalence that are not described in the guidance.

  • Special controls

The use of special control may also facilitate the review through reliance on a summary report that describes how a special control has been used to address a special risk or issue. Special controls are defined in section 513(a)(1)(B) of the FD&C Act as those controls, such as performance standards, postmarketing surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions that provide reasonable assurance of device’s safety and effectiveness.

  • Voluntary consensus standards

Manufacturers submitting an abbreviated 510(k) that relies on general use of a voluntary consensus standard should include a summary report describing the basis of such use along with the underlying information or data that supports how the standard was used.

The guidances “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER” should be consulted.

Appendix A of the September 2019 guidance should be carefully referenced along with two other FDA guidances: “Refuse to Accept Policy for 510(K)s” and “Format for Traditional and Abbreviated 510(K)s”.

FDA believes that its review of abbreviated 510(k)s may be more efficient than that of traditional 510(k) submissions allowing for more efficient use of FDA’s review resources. However, FDA still intends to review abbreviated 510(k)s within the 90 days specified for 510(k) applications in the 2017 Medical Device User Fee Amendments, which is the same as the review period for a traditional 510(k).

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