Feb 20

New FDA Guidances for January 2018

By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research

 

FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted.  CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority of guidance documents.  CDRH is also intending to conduct a focused retrospective review of guidances released in 2008, 1998, 1988, and 1978.  More information can be found here:   https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm

In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Qualified Infectious Disease Product Designation Questions and Answers 29 Jan 2018
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry – Draft Guidance 25 Jan 2018
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Jan 2018
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft Guidance 18 Jan 2018
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff  – Final Guidance 16 Jan 2018
Good ANDA Submission Practices Guidance for Industry – Draft Guidance 03 Jan 2018
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry – Draft Guidance 02 Jan 2018
Upcoming Meetings (* = New)
March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
* March 8, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
* March 22, 2018: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* March 23, 2018: Pediatric Advisory Committee Meeting Announcement
Last updated: 15 February 2018

Feb 15

What’s New Health Canada?

By Sandra Salem, Ph.D., Regulatory Scientist

 

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

 

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

 

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

 

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

 

Health Canada New Guidance Documents (Drugs, Biologics, Medical Devices and Natural & Non-prescription Health Products)

 

Health Canada Guidance Type Date Posted
Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs Guidance 11 December 2017
Guidance Document: Classification of Products at the (Medical) Device-Drug Interface Guidance 08 February 2018

 

Updates from Health Canada (Drugs, Biologics, Medical Devices and Natural & Non-prescription Health Products)

 

Type of Update and Link Date Posted
Updated: Notice – Mandatory use of the Electronic Common Technical Document (eCTD) format 12 January 2018
Notice: Adoption of International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: M7 19 January 2018

 

  

 

Santé Canada: Quoi de neuf?

 

Par Sandra Salem, Ph.D., Scientifique Réglementaire

 

Quoi de neuf :

Direction des produits thérapeutiques

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/quoi-neuf-medicaments-sante-canada.html

 

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

 

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

 

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 

Nouvelles lignes directrices de Santé Canada (Médicaments, Produits biologiques, Instruments médicaux et Produits de santé naturels et sans ordonnance)

 

Ligne directrice de Santé Canada Genre Date
Publication de la version définitive de la Ligne directrice : Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants ligne directrice 11 décembre 2017
Ligne directrice : Classification des produits situés à la frontière entre les instruments (médicaux) et les drogues ligne directrice 08 février 2018

 

Mises à jour de Santé Canada (Médicaments, Produits biologiques, Instruments médicaux et Produits de santé naturels et sans ordonnance)

 

Genre de mise à jour et lien Date
Mises à jour : Avis – Utilisation obligatoire du format Electronic Common Technical Document (eCTD) 12 janvier 2017
Avis : L’adoption des lignes directices M7 de l’International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) 19 janvier 2017

 

Jan 22

Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

By: Robert McNeill, Ph.D., Scientist at Cato Research

In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were withdrawn: “Formal Meetings between the FDA and Sponsors or Applicants”, published 19 May 2009 and “Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products”, Revision 2, published 11 March 2015 (2015 PDUFA Meetings draft guidance).

The 2017 PDUFA Meetings draft guidance provides FDA’s recommendations for the formal meetings with the FDA defined under PDUFA VI. As in the previous version, the guidance addresses meetings related to the development and review of drug or biological drug products. This guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. Although the 2017 PDUFA Meetings draft guidance is similar to the prior draft guidance, there are some important changes:

Content of meeting requests and meeting packages:

  • Information required to be included in a meeting request is now defined. For example, a list of requested FDA attendees is now required, and justification should be provided for the request of nonessential FDA staff.
  • New details are now recommended to be included in a meeting request and in a meeting package. For example, the proposed regulatory pathway – e.g., 505(b)(1), 505(b)(2) – should now be included in both documents.

Type and format of meetings:

  • There are now four defined meeting types: Type A, Type B, Type B (end of phase [EOP]), and Type C.
  • FDA specifies that any meeting format can be requested for any type of meeting (i.e. face-to-face, videoconference, teleconference, or written response only). This was limited in the previous guidance.
  • Type C meetings can now be held, in some cases, to provide early consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval.
  • End-of-phase 2 meetings, pre-phase 3 meetings and certain end-of-phase 1 meetings are now classified as Type B (EOP) meetings, instead of Type B meetings.
  • As always, it remains the FDA’s prerogative to decide whether to grant a meeting, the final meeting type, and the appropriate meeting format, and importantly…
  • FDA advises sponsors and applicants to contact the review division or office to discuss the appropriateness of a Type A meeting request before submitting a meeting request.

Timelines for formal meetings:

Important timelines are nicely summarized in tables within the 2017 PDUFA Meetings draft guidance. Key information and changes include:

  • As before, Type B meetings will be schedule within 60 days of the request with the information package due at least 1 month prior to the meeting.
  • The new Type B (EOP) meetings will be scheduled within 70 days of the request with the information package due at least 50 days prior to the meeting.
  • For Type C meetings to provide consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval, the information package must be submitted at the time of the request.
  • For other Type C meetings, the information package must now be submitted at least 47 days before the meeting date (instead of the previous 1 month deadline).
  • Preliminary responses from the FDA should now be sent no later than five days before Type B(EOP) meetings and Type C meetings, instead of at least 2 days before the meeting.
  • The requester will now have to notify the FDA whether Type B (EOP) meetings and Type C meetings meeting are still needed within three days of the meeting.

Other new information

  • More detailed information on the content of FDA’s meeting minutes.
  • A request from CDER to bring desk copies of meeting packages submitted electronically to the meeting.
  • A statement that CBER does not request nor accept desk copies of electronically submitted meeting packages.

The PDUFA Meetings draft guidance 2017 is an essential document for sponsors and applicants when considering formal communications with the FDA. Adhering to these recommendations will help ensure successful and informative meetings with the FDA for drug and biological drug products. This draft guidance is currently open for public comments until 29 March 2018.

Jan 17

South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa

 

On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new regulator will be responsible for the evaluation and registration of medicines (including complimentary medicines), as well as medical devices and in-vitro diagnostics. The Authority will also ensure that clinical trial protocols are being assessed according to prescribed ethical and professional criteria and defined standards.

 

A government notice requesting nominations for the Board of SAHPRA was published on 06 June 2017 and on 09 October 2017 the Minister of Health published the names of the 15 members of the Board. (The Minister of Health appoints the Board members of SAHPRA, and SAHPRA acts through its Board.) The Board have been appointed for a 3 year term of office, expiring on 30 September 2020.

 

Although the Board has been appointed, a number of items need to take place before the SAHPRA formally take over from the current regulator, the Medicines Control Council (MCC). Some of these are described in Section 26 (Transitional Arrangements) of Act 14 of 2015 (which also came into operation when Act 72 of 2008 was proclaimed) and include the transition of staff, movable property and pending registration applications. In addition to these Transitional Arrangements, another key step is for the Treasury to formally approve SAHPRA as a Section 3a Public Entity. so that it can retain revenue*.

 

As SAHPRA will have the power to retain the registration and clinical trials application fees, as well as other fees, it generates and is allowed to remunerate staff at rates higher than those typically paid in the public service, it is expected that this will enhance its ability to attract and retain staff. The State, through the Department of Health, is expected to fund SAHPRA initially but the Authority is ultimately expected to secure 70% of its budget from fees.

 

The MCC will continue to exist and carry out its functions until the day before the first meeting of the SAHPRA. This meeting will be on a date determined by the Minister of Health but is largely expected to be in the first quarter of 2018. As described in the Transitional Arrangements, all previous decisions, guidelines and procedures that are within the scope of the SAHPRA’s functions, and which are in force on the day of the first Board meeting date will remain in force until they are amended or repealed by the SAHPRA.

 

*A Section 3A Public Entity (or national government business enterprise) is normally an extension of a public entity with the mandate to fulfil a specific economic or social responsibility of government. It relies on government funding and public money. Examples are the South African Revenue Service, South African National Parks and National Health Laboratory Service.

 

Jan 05

New FDA Guidances for December 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in December 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Labeling for Combined Hormonal Contraceptives – Draft Guidance 29 Dec 2017
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry – Final Guidance 28 Dec 2017
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products – Draft Guidance 28 Dec 2017
Best Practices for Communication Between IND Sponsors and FDA During Drug Development – Final Guidance 28 Dec 2017
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers – Draft Guidance 26 Dec 2017
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products– Draft Guidance 21 Dec 2017
Amendment to Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products – Draft Guidance 21 Dec 2017
Medical Device Accessories – Describing Accessories and Classification Pathways – Final Guidance 20 Dec 2017
Clarification of Orphan Designation of Drugs and Biologics for Pediatrics – Draft Guidance 19 Dec 2017
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices – Draft Guidance 19 Dec 2017
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Draft Guidance 18 Dec 2017
Drug Products Labeled as Homeopathic – Draft Guidance 18 Dec 2017
Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance 18 Dec 2017
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease – Draft Guidance 15 Dec 2017
Drug Products, Including Biological Products, that Contain Nanomaterials – Draft Guidance 15 Dec 2017
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments – Draft Guidance 15 Dec 2017
The Least Burdensome Provisions: Concept and Principles – Draft Guidance 15 Dec 2017
An Acceptable Circular of Information for the Use of Human Blood and Blood Components – Final Guidance 14 Dec 2017
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs – Final Guidance 13 Dec 2017
Gluten in Drug Products and Associated Labeling Recommendations – Draft Guidance 12 Dec 2017
Refuse to File: NDA and BLA Submissions to CDER – Draft Guidance 12 Dec 2017
Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use – Final Guidance 12 Dec 2017
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling – Final Guidance 11 Dec 2017
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Draft Guidance 08 Dec 2017
Software as a Medical Device (SAMD): Clinical Evaluation – Final Guidance 08 Dec 2017
Clinical and Patient Decision Support Software – Draft Guidance 08 Dec 2017
Pediatric Rare Diseases–A Collaborative Approach for Drug Development Using Gaucher Disease as a Model – Draft Guidance 06 Dec 2017
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components – Final Guidance 05 Dec 2017
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions – Final Guidance 05 Dec 2017
Technical Considerations for Additive Manufactured Medical Devices – Final Guidance 05 Dec 2017
Providing Regulatory Submissions in Electronic Format – Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling – Draft Guidance 01 Sep 2017
Upcoming Meetings (* = New)
* January 9, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 10, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 11, 2018: Meeting of the Antimicrobial Drugs Advisory Committee
* January 24, 2018: Tobacco Products Scientific Advisory Committee
* March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
Last updated: 02 January 2018

 

Dec 22

What’s New Health Canada?

By Amelie Rodrigue-Way, PhD, RAC (CAN), Associate Director, Regulatory Strategy

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

 Health Canada New Guidance Documents (Drugs and Biologics)

 

Health Canada Guidance Type Date Posted
Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Guidance 30 October 2017
Addendum – Quality (Chemistry and Manufacturing) Guidance: Questions and Answers Guidance 30 October 2017
Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product Guidance 27 November 2017

 

Updates from Health Canada (Drugs and Biologics) 

Type of Update and Link Date Posted
Notice – Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format 27 November 2017

 

   

Santé Canada: Quoi de neuf?

Par Amelie Rodrigue-Way, PhD, RAC(CAN), Associate Director, Regulatory Strategy

Quoi de neuf :

Direction des produits thérapeutiques

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/quoi-neuf-medicaments-sante-canada.html

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques) 

Ligne directrice de Santé Canada Genre Date
Ligne directrice sur le document certifié d’information sur les produits – Entités chimiques ligne directrice 30 octobre 2017
Addenda – Qualité (chimie et fabrication) : Questions et réponses ligne directrice 30 octobre 2017
ligne directrice Utilisation d’un produit de référence étranger comme produit de référence canadien ligne directrice 27 novembre 2017

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques) 

Genre de mise à jour et lien Date
Avis – Règles de validation des transactions réglementaires soumises par Santé Canada en format electronic Common Technical Document (eCTD) [ 27 novembre 2017

 

Dec 20

New FDA Guidances for October and November 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in October and November 2017 are posted. Currently, there are no upcoming advisory committee meetings.

Special Interest Guidances/Information Date Posted
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices – Draft Guidance 29 Nov 2017
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies – Draft Guidance 29 Nov 2017
Pediatric Information for X-ray Imaging Device Premarket Notifications – Final Guidance 28 Nov 2017
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier – Draft Guidance 27 Nov 2017
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products – Final Guidance 21 Nov 2017
Unique Device Identification: Direct Marking of Devices – Final Guidance 17 Nov 2017
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions – Draft Guidance 16 Nov 2017
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies – Draft Guidance 16 Nov 2017
Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception – Final Guidance 16 Nov 2017
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 – Draft Guidance 15 Nov 2017
S5(R3) Detection of Toxicity to Reproduction – Draft Guidance 09 Nov 2017
Use of a Drug Master File for Shared System REMS Submissions – Draft Guidance 08 Nov 2017
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle – Final Guidance 08 Nov 2017
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention – Final Guidance 06 Nov 2017
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment – Draft Guidance 06 Nov 2017
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery – Final Guidance 06 Nov 2017
Formal Dispute Resolution: Appeals Above the Division Level – Final Guidance 03 Nov 2017
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) – Draft Guidance 03 Nov 2017
Controlled Correspondence Related to Generic Drug Development – Draft Guidance 02 Nov 2017
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices – Final Guidance 30 Oct 2017
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials – Draft Guidance 30 Oct 2017
De Novo Classification Process (Evaluation of Automatic Class III Designation) – Final Guidance 30 Oct 2017
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request – Final Guidance 30 Oct 2017
Acceptance Review for De Novo Classification Requests – Draft Guidance 30 Oct 2017
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 27 Oct 2017
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment – Draft Guidance 26 Oct 2017
In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies – Draft Guidance 25 Oct 2017
Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications – Draft Guidance 25 Oct 2017
Breakthrough Devices Program – Draft Guidance 25 Oct 2017
Deciding When to Submit a 510(k) for a Change to an Existing Device – Final Guidance 25 Oct 2017
Deciding When to Submit a 510(k) for a Software Change to an Existing Device – Final Guidance 25 Oct 2017
Salmeterol Xinafoate_020692 – Draft Guidance 18 Oct 2017
Fluticasone propionate_021433 – Draft Guidance 18 Oct 2017
Fluticasone propionate_020833 – Draft Guidance 18 Oct 2017
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA – Draft Guidance 13 Oct 2017
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 – Draft Guidance 12 Oct 2017
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment – Draft Guidance 11 Oct 2017
Format and Content of a REMS Document – Draft Guidance 11 Oct 2017
Determining Whether to Submit an ANDA or a 505(b)(2) Application – Draft Guidance 11 Oct 2017
Requests for Reconsideration at the Division Level Under GDUFA – Draft Guidance 11 Oct 2017
ANDA Submissions – Prior Approval Supplements Under GDUFA – Final Guidance 04 Oct 2017
Completeness Assessments for Type II API DMFs Under GDUFA – Final Guidance 04 Oct 2017
Individual Patient Expanded Access Applications: Form FDA 3926 – Final Guidance 03 Oct 2017
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Final Guidance 03 Oct 2017
Expanded Access to Investigational Drugs for Treatment Use — Qs & As – Final Guidance 03 Oct 2017
Waiver of IRB Requirements for Drug and Biological Product Studies – Information Sheet – Final Guidance 03 Oct 2017
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff – Final Guidance 02 Oct 2017
User Fees and Refunds for Premarket Notification Submissions (510(k)s) – Final Guidance 02 Oct 2017
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA – Draft Guidance 02 Oct 2017
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA – Draft Guidance 02 Oct 2017
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) – Draft Guidance 02 Oct 2017
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin – Draft Guidance 02 Oct 2017
User Fees for 513(g) Requests for Information – Final Guidance 02 Oct 2017
User Fees and Refunds for De Novo Classification Requests – Final Guidance 02 Oct 2017
ANDA Submissions – Refuse-to-Receive Standards: : Questions and Answers – Draft Guidance 02 Oct 2017
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers – Draft Guidance 02 Oct 2017
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications – Final Guidance 02 Oct 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Prioritization of the Review of Original ANDAs, Amendments, and Supplements 09 Nov 2017
Developing and Issuing Drug Trial Snapshots 26 Oct 2017
CMC Reviews of Type III DMF’s for Packaging Materials 18 Oct 2017
Communicating Abbreviated New Drug Application Review Status Updates with Industry 06 Oct 2017
Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA 04 Oct 2017
Last updated: 15 December 2017  

Dec 07

Toward Compliance 2.0 : When your Pill is Connected to your Smartphone

By: David Hamel, Fellow Scientist Cato Research Canada

The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults could mark a new era in patients’ medication adherence technology. The new product combines the antipsychotic aripiprazole in its tablet formulation and a drug ingestion tracking system comprised of an Ingestible Event Marker (IEM) sensor, a wearable patch (MyCite Patch), a mobile application, and a web-based portal, that identifies and relay drug ingestion events to the patient’s smartphone. In addition, the patient can permit their caregivers and physician to access the information through the web-based portal. This is the first drug with a digital tracking system approved in the U.S. Although, Abilify MyCite was not designed to improve patient compliance or modify drug dosage, this technology could eventually be paving the way for a new standard in medication adherence and chronic disease management.

 

The FDA approved aripiprazole in 2002 for the treatment of schizophrenia.[1] Since then, the drug was approved for bipolar I disorder (September 2004) and as an adjunctive treatment of major depressive disorder in adults (November 2007). The FDA approved the ingestible sensor for marketing in 2012.[2] The true innovation of Abilify MyCite resides in its integrated tracking system. At the core of this technology lies a 1-mm sized sensor activated by the reaction between two of its constituents, magnesium and cuprous chloride, in the presence of gastric fluid, which power the sensor. The signal is detected by a wearable sensor (MyCite Patch) located on the patient’s torso, which in turn relays the ingestion event to an application on the patient’s mobile device. In practice, the ingestion events can be detected between 30 minutes and 2 hours after each dose. The patch, which can be worn while showering, swimming or exercising, should be changed at least every week, and be located within 9-foot of the paired smartphone to properly communicate the information. Preclinical studies assessed the safety of ingesting the Event Marker.[3] The safety profile supports the use of the technology in the treatment of chronic diseases.

 

While the approval is an excellent news for individuals suffering from mental disorders, patients affected by other chronic diseases could in theory benefit from the deployment of this technology in other therapeutics areas, such as AIDS, asthma, tuberculosis, hypertension and organ transplant[4], in which medication compliance is also critical. While the stated objective supporting the marketing of the Ingestible Event Marker is to provide better information to healthcare providers, the companies remain in a grey area between simple information and the objective quantification of adherence. Therefore, further studies designed to evaluate the impact of Abilify MyCite on compliance would be required.

 

We should also consider the impact of system defects and improper use on the treatment. Whether a faulty detection or software glitch, the risk of inadequately capturing the ingestion events would prevent healthcare providers from adequately determining if patients are taking their medication. Alternatively, this improper tracking could also lead to patients taking more than the prescribed dose. The Prescribing Information indicates the possibility that the ingestion of the tablet may not be detected. To avoid this, patients should receive adequate training on how to position and pair the patch with the application. Proteus Digital Health, the device developer and manufacturer of the system, reported a detection accuracy of 99.1% during clinical trials. They attributed faulty detections to a combination of stomach environment and receiver-sensor orientation.[5]

 

As with many new technologies, concerns over privacy can be raised. For example, we can consider the security of software and servers necessary to transmit the relevant information to healthcare providers. Will they be sufficiently secured and properly maintained? Who will have access to the information and who will make the choice to grant access to certain individuals or not? What about patients with severe cognitive impairment unable to permit their caregivers and physician to access their information? We can also contemplate a future where insurers could require a “proof of ingestion” before reimbursing the treatment.

 

Abilify MyCite clinical studies demonstrated that the device was safe and that this technology could provide reliable and accurate information with manageable risks to patients. This new combination product could provide physician valuable insight into their patients’ behavior and ultimately guide the discussion on how to improve their treatment.

 

For more information about Abilify MyCite visit:

 

FDA New Release (November 13, 2017): https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm?utm_campaign=FDA%20approves%20pill%20with%20sensor%20that%20digitally%20tracks%20if%20patients%20have%20ingested%20their%20medication&utm_medium=email&utm_source=Eloqua

 

Otsuka America Pharmaceutical: https://www.otsuka-us.com/discover/articles-1075

 

Proteus Digital Health: http://www.proteus.com/press-releases/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor-2/

 

[1] FDA Approval Enclosure documentation

[2] Proteus Digital Health, press release 30 July 2012, online at http://www.proteus.com/press-releases/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor-2/

[3] Hafezi H et al., An Ingestible Sensor for Measuring Medication Adherence IEEE Transactions on Biomedical Engineering, vol 62, NO. 1, January 2015

[4] Sabaté E, editor. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003

[5] Hafezi H et al., An Ingestible Sensor for Measuring Medication Adherence IEEE Transactions on Biomedical Engineering, vol 62, NO. 1, January 2015.

Oct 18

What’s New Health Canada?

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate II

 

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

 

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

Health Canada New Guidance Documents (Drugs and Biologics)

Health Canada Guidance Type Date Posted
Publication of the Guidance Document: Certificate of Supplementary Protection Regulations Guidance 19 September 2017
Publication of the Health Canada Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions Guidance 21 August 2017

 

Updates from Health Canada (Drugs and Biologics)

Type of Update and Link Date Posted
Updated Notice: Interim Policy on Health Canada’s Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient 05 October 2017
Consultation: Release of Draft (Step 2) ICH Guidance: E9(R1): Addendum: Statistical Principles for Clinical Trials 05 October 2017
Consultation: Release of Draft (Step 2) ICH Guidance: S5(R3): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals 05 October 2017
Notice – Patented Medicines (Notice of Compliance) Regulations 19 September 2017
Notice: eCTD Pilot for Clinical Trial Regulatory Activities – Extension 28 August 2017
Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation (ICH) 25 August 2017

 

 Santé Canada: Quoi de neuf?

Par Christine Straccini, B.Sc., Associée réglementaire II

 

Quoi de neuf :

Direction des produits thérapeutiques:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/quoi-neuf-medicaments-sante-canada.html

 

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 

Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques)

 Ligne directrice de Santé Canada

Genre Date
Publication de la ligne directrice : Règlement sur les certificats de protection supplémentaire ligne directrice 19 septembre 2017
Publication de la ligne directrice de Santé Canada : Utilisation de certificats de conformité à titre d’information à l’appui des présentations de drogue ligne directrice 21 août 2017

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques)

 

Genre de mise à jour et lien Date
Avis mis à jour : Politique provisoire sur l’interprétation du terme « ingrédient médicinal » et sur l’évaluation d’un « ingrédient médicinal identique » par Santé Canada 05 octobre 2017
Consultation : Publication de l’ébauche (étape 2) ICH Guidance: E9(R1): Addendum: Statistical Principles for Clinical Trials 05 octobre 2017
Consultation : Publication de l’ébauche (étape 2) ICH Guidance: S5(R3): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals 05 octobre 2017
Avis : Règlement sur les médicaments brevetés (avis de conformité) 19 septembre 2017
Avis : Projet pilote sur le format eCTD pour les activités de réglementation liées aux études cliniques – Prolongation 28 août 2017
Avis: Santé Canada et États-Unis Food and Drug Administration Consultation publique mixte sur la Conférence internationale sur l’International Council for Harmonisation (ICH) 25 août 2017

 

Oct 11

New FDA Guidances for September 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in September 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions – Final Guidance 29 Sep 2017
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A – Final Guidance 29 Sep 2017
Display Devices for Diagnostic Radiology – Final Guidance 29 Sep 2017
Administrative Procedures for CLIA Categorization – Final Guidance 29 Sep 2017
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations – Draft Guidance 28 Sep 2017
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization – Final Guidance 28 Sep 2017
Classification of Products as Drugs and Devices and Additional Product Classification Issues – Final Guidance 25 Sep 2017
Expedited Programs for Serious Conditions – Drugs and Biologics – Final Guidance 22 Sep 2017
Statistical Approaches to Evaluate Analytical Similarity – Draft Guidance 21 Sep 2017
Q4B Annex I: Residue on Ignition/Sulphated Ash General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 5: Disintegration Test General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 8: Sterility Test General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 9: Tablet Friability General Chapter – Final Guidance 18 Sep 2017
Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter – Final Guidance 18 Sep 2017
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses – Final Guidance 15 Sep 2017
Regulatory Considerations for Microneedling Devices – Draft Guidance 15 Sep 2017
Utilizing Animal Studies to Evaluate Organ Preservation Devices – Draft Guidance 12 Sep 2017
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations – Draft Guidance 12 Sep 2017
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies – Final Guidance 12 Sep 2017
Guidance Agenda: Guidances CDER is Planning… 12 Sep 2017
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Final Guidance 06 Sep 2017
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 – Final Guidance 06 Sep 2017
Procedures for Meetings of the Medical Devices Advisory Committee – Final Guidance 01 Sep 2017
Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday – Final Guidance 01 Sep 2017
Providing Regulatory Submissions in Electronic Format – Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling – Draft Guidance 01 Sep 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Process for Evaluating Emerging Technologies Related to Quality 28 Sep 2017
Environmental Assessments and Claims of Categorical Exclusion 14 Sep 2017
Filing Review of Abbreviated New Drug Applications 01 Sep 2017
Upcoming Meetings (* = New)
* October 4, 2017: Vaccines and Related Biological Products Advisory Committee
  October 11-12, 2017: Patient Engagement Advisory Committee
* October 12, 2017: Cellular, Tissue and Gene Therapies Advisory Committee
* October 13, 2017: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee
* October 31, 2017: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
* November 1, 2017: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
* November 7, 2017: Vaccines and Related Biological Products Advisory Committee
* November 16, 2017: Meeting of the Antimicrobial Drugs Advisory Committee
  December 7, 2017: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
Last updated: 03 October 2017

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