New FDA Guidances for February 2017

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

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

Special Interest Guidances/Information Date Posted
Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials – Draft Guidance 17 Feb 2017
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy – Final Guidance 16 Feb 2017
Guidance Agenda: Guidances CDER is Planning… – Draft Guidance 15 Feb 2017
Dear Health Care Provider Letters: Improving Communication of Important Safety Information – Final Guidance 08 Feb 2017
Upcoming Meetings (* = New)
Pediatric Advisory Committee Meeting; 06 March 2017; Silver Spring, MD
Pediatric Advisory Committee Meeting; 07 March 2017; Silver Spring, MD
Vaccines and Related Biological Products Committee Meeting; 09 March 2017; Rockville, MD
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; 13-14 March 2017; Silver Spring, MD
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting; 15 March 2017; Washington, DC
Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; 17 March 2017; Gaithersburg, MD
* Blood Products Advisory Committee Meeting; 4-5 April 2017; Silver Spring, MD
2017 Advisory Committee Tentative Meetings
* new entry
Last updated: 01 March 2017
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What’s New Health Canada? February 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada

 

What’s New in:

Therapeutic Products Directorate:

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

Biologics and Genetic Therapies Directorate:

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

Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php

 

Health Canada New Guidance Documents (Drugs and Biologics):

January-February 2017

Health Canada Guidance Type Date Posted
Use of Certificates of Suitability as supporting information in Drug Submissions Consultation Document

 

Draft Guidance 31 Jan 2017

 

Updates from Health Canada (Drugs and Biologics):

January-February 2017

Type of Update and Link Date Posted
Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities 18 Jan 2017
Updated ICH Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products 19 Jan 2017
Record of Proceedings for Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) for 2016-10-06 Meeting 23 Jan 2017
Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions 31 Jan 2017
Notice – Submission Filing Requirements – Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) 02 Feb 2017
Consultation: Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) “Renovation” Reflection Paper 02 Feb 2017

Santé Canada: Quoi de neuf?

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie réglementaire, et Christine Straccini, B.Sc., Associée réglementaire ; Cato Recherche Canada

Quoi de neuf :

Direction des produits thérapeutiques

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

Direction des produits biologiques et thérapies génétiques:

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

Instruments médicaux: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-fra.php

Direction des produits de santé naturels et sans ordonnance:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-fra.php

 

 

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

Janvier-Février 2017

Ligne directrice de Santé Canada Genre Date
Utilisation de certificats de conformité à titre d’information à l’appui des présentations de drogue Document de consultation Ébauche de la ligne directrice 31 Jan 2017

 

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

Janvier-Février 2017

Genre de mise à jour et lien Date
Avis mis à jour: Projet pilote sur le format eCTD pour les activités de réglementation liées aux études cliniques 18 Jan 2017
Q3D Avis mis à jour : Recommandations de Santé Canada sur la mise en œuvre de la directive harmonisée de l’ICH concernant les impuretés élémentaires (Q3D) pour les nouveaux produits et les produits commercialisés 19 Jan 2017
Compte rendu des délibérations du groupe consultatif scientifique sur les traitements anti-infectieux (GCS-TAI) pour la rencontre du 06-10-2016 23 Jan 2017
Consultation sur l’ébauche de la ligne directrice de Santé Canada – Utilisation de certificats de conformité à titre d’information à l’appui des présentations de drogue 31 Jan 2017
Avis : Exigences relatives au dépôt de présentations – Bonnes pratiques de fabrication (BPF) et licences d’établissement de produits pharmaceutiques (LEPP) 02 Fév 2017
Consultation: Publication de document l’International Council for Harmonisation (l’ICH) : Good Clinical Practice (GCP) « Renovation » Reflection paper 02 Fév 2017

 

 

Posted in Canadian Regulatory Affairs, Cato Research | Tagged , | Comments Off on What’s New Health Canada? February 2017

A New Expedited Review Designation: Regenerative Advanced Therapy

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

One of the many changes brought by the 21st Century Cures Act is the new expedited review designation entitled Regenerative Advanced Therapy (with the unfortunate acronym of RAT).

FDA provides brief guidance for a RAT designation on their website (provided below). A drug is eligible for RAT designation if:

  • “the drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
  • the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.”1,2

While the benefits of RAT designation are less clearly defined than its more established expedited review designation counterparts (i.e., breakthrough therapy, fast track, accelerated approval, priority review), FDA does outline the following benefits of RAT designation:

  • early interactions to discuss potential surrogate or intermediate endpoints to support accelerated approval of an application;
  • eligibility for priority review; and
  • eligibility for accelerated approval.1

Primary data is not required to apply for RAT designation, but the RAT designation request should at least describe preliminary clinical evidence. The RAT designation request can be submitted with an Investigational New Drug application (IND) or as an amendment to an existing, cleared IND.

The submission process for RAT designation requests is detailed on the FDA website.2

Guidance on RAT designation:

  1. 21st Century Cures Act, Section 3033
  2. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

Posted in Cato Research, Drug Development, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , , | Comments Off on A New Expedited Review Designation: Regenerative Advanced Therapy

New FDA Guidances for January 2017

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

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

Special Interest Guidances/Information Date Posted
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance 18 Jan 2017
Considerations in Demonstrating Interchangeability With a Reference Product – Draft Guidance 17 Jan 2017
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers – Draft Guidance 17 Jan 2017
Assessment of Abuse Potential of Drugs – Final Guidance 17 Jan 2017
2016 Medical Gas Container-Closure Rule Questions and Answers – Final Guidance 17 Jan 2017
Emergency Use Authorization of Medical Products and Related Authorities – Final Guidance 13 Jan 2017
How to Prepare a Pre-Request for Designation (Pre-RFD) – Draft Guidance 13 Jan 2017
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Final Guidance 13 Jan 2017
Referencing Approved Drug Products in ANDA Submissions – Draft Guidance 13 Jan 2017
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA – Draft Guidance 13 Jan 2017
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Final Guidance 13 Jan 2017
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act – Final Guidance 13 Jan 2017
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities – Final Guidance 12 Jan 2017
Guidance for Industry 180-Day Exclusivity: Questions and Answers – Draft Guidance 12 Jan 2017
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Draft Guidance 12 Jan 2017
Multiple Endpoints in Clinical Trials – Draft Guidance 12 Jan 2017
Nonproprietary Naming of Biological Products – Final Guidance 12 Jan 2017
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions – Final Guidance 11 Jan 2017
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery – Draft Guidance 11 Jan 2017
Guidance Agenda: Guidances CDER is Planning… 11 Jan 2017
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus – Final Guidance 10 Jan 2017
Current Good Manufacturing Practice Requirements for Combination Products – Final Guidance 10 Jan 2017
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers – Draft Guidance 09 Jan 2017
Labeling of Red Blood Cell Units with Historical Antigen Typing Results – Draft Guidance 03 Jan 2017
Premarket Notification (510(k)) Submissions for Bone Anchors – Draft Guidance 03 Jan 2017
Upcoming Meetings (* = New)
* Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting; 23 February 2017; Gaithersburg, MD
* Pediatric Advisory Committee Meeting; 06 March 2017; Silver Spring, MD
* Pediatric Advisory Committee Meeting; 07 March 2017; Silver Spring, MD
* Vaccines and Related Biological Products Committee Meeting; 09 March 2017; Rockville, MD
* Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; 13-14 March 2017; Hyattsville, MD
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting; 15 March 2017; Washington, DC
* Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; 17 March 2017; Gaithersburg, MD
2017 Advisory Committee Tentative Meetings
Posted in Cato Research, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Comments Off on New FDA Guidances for January 2017

What’s New Health Canada? Jan 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada

 

What’s New in:

Therapeutic Products Directorate:

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

Biologics and Genetic Therapies Directorate:

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

Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php

 

 

Health Canada New Guidance Documents (Drugs and Biologics):

October – December 2016

 

Health Canada Guidance/Notice

Type

Date Posted
Updated – Guidance Document: Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” Format

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/gd_prep_non_ectd_ld-eng.php

Guidance

14 Dec 2016
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/biosimilars-biosimilaires-eng.php

Guidance

02 Dec 2016
Patented Medicines (Notice of Compliance) Regulations

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.pdf

Draft Guidance

27 Oct 2016
How to Pay Fees to Health Products and Food Branch (HPFB)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/costs-couts/crpay_rcfrais_for-eng.php

Guidance

19 Oct 2016
Post-Notice of Compliance (NOC) Changes: Quality Document

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php

Guidance

14 Oct 2016
Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-ndsands-draft-ebauche-pdnpadn-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-adden-gd-draft-ebauche-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-gloss-term-gd-draft-ebauche-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/cpidce-gd-draft-ebauche-ld-dcipec-eng.php

This consultation was open for comment until December 4, 2016

Draft Guidance

2016/08/31

05 Oct 2016

Updates from Health Canada (Drugs and Biologics)

Type of Update and Link Date Posted
Notice: Mandatory Requirements for using the Common Electronic Submissions Gateway (CESG) 28 Dec 2016
Notice: Final Release: Part I – Health Professional Information and Part II – Scientific Information of the Guidance Document – Product Monograph 09 Dec 2016
Fact Sheet: Biosimilars

 

07 Dec 2016
Register of Innovative drugs

 

02 Dec 2016
Notice – Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format 01 Dec 2016
Notice: Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

 

04 Nov 2016
Notice: Release of the revised Post-Notice of Compliance (NOC) Changes – Quality Guidance

 

03 Nov 2016
Notice – Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form

 

03 Nov 2016
Product Monograph Brand Safety Updates

 

19 Oct 2016
Posted in Cato Research, Drug Development, Health Canada, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Comments Off on What’s New Health Canada? Jan 2017