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Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance 18 Jan 2017
Considerations in Demonstrating Interchangeability With a Reference Product – Draft Guidance 17 Jan 2017
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers – Draft Guidance 17 Jan 2017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How to Prepare a Pre-Request for Designation (Pre-RFD) – Draft Guidance 13 Jan 2017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Referencing Approved Drug Products in ANDA Submissions – Draft Guidance 13 Jan 2017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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA – Draft Guidance 13 Jan 2017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Guidance for Industry 180-Day Exclusivity: Questions and Answers – Draft Guidance 12 Jan 2017
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Draft Guidance 12 Jan 2017
Multiple Endpoints in Clinical Trials – Draft Guidance 12 Jan 2017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

New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. – Final Guidance 30 Dec 2016
Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 30 Dec 2016
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 28 Dec 2016
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry – Draft Guidance 28 Dec 2016
Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry – Draft Guidance 28 Dec 2016
Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry – Draft Guidance 28 Dec 2016
Botanical Drug Development: Guidance for Industry – Final Guidance 28 Dec 2016
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product – Final Guidance 28 Dec 2016
Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff – Final Guidance 28 Dec 2016
ANDA Submissions — Refuse-to-Receive Standards Rev.2 -Final Guidance 21 Dec 2016
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers – Final Guidance 14 Dec 2016
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 14 Dec 2016
Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry – Final Guidance 12 Dec 2016
Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 12 Dec 2016
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry – Final Guidance 08 Dec 2016
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format – Final Guidance 02 Dec 2016
Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry – Draft Guidance 01 Dec 2016
Upcoming Meetings (* = New)
* March 15, 2017: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
* 2017 Advisory Committee Tentative Meetings
* new entry
Last updated: 06 January 2017
Posted in Cato Research, Clinical Trials, FDA, Regulatory Strategy, Regulatory Submissions, Uncategorized | Tagged , , | Comments Off on New FDA Guidances for December 2016

Transparency Initiatives at Health Canada

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy for Cato Research Canada.

As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php), Health Canada has committed to provide greater transparency and openness to further strengthen trust in their regulatory decisions.

The Framework will:

  • Help Canadians to better understand how and why decisions are made. Canadians will be able to use this information to make well-informed decisions on their health and the health of their families.
  • Assist industry to be better positioned to comply with current regulatory requirements and plan for upcoming regulatory changes.

 

Since 2012, Summary Basis of Decision (SBD) documents are published for ‘novel’ drugs and devices: New Drug Submissions for New Active Substances and a subset of Class IV medical device applications. The SBD documents explain why Health Canada authorized certain drugs for sale in Canada. The documents include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations.

Under the transparency initiatives, the Health Products and Food Branch (HPFB) proceeded since May 2016 with Phase II of the Regulatory Decision Summary (RDS) and Submissions Under Review (SUR) List initiatives.

 

Submissions Under Review (SUR)

Canadians can access the list of certain drug submissions currently under review. These submissions include new drug submissions (NDSs) containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. This applies to submissions whose review started on or after 01 April 1 2015.

The following are now included on the SUR List as part of Phase II of the Transparency Initiatives:

– Medicinal ingredient and therapeutic class for all NDSs and SNDSs for new indications for pharmaceuticals and biologics accepted into review on or after 01 May 2016

The entry for each submission includes its medicinal ingredient(s) and therapeutic area but not the manufacturer. The list is updated monthly.

A substance is removed from these lists:

  • once a final decision is made and the submission is no longer under review
  • if the submission is cancelled

Canadians can see if a submission has been approved in the Notice of Compliance Database. In addition, an explanation of the decision (positive or negative) or cancellation in the Regulatory Decision Summary (RDS) will be available. If applicable, a more detailed explanation is also contained in a Summary Basis of Decision document.

 

Regulatory Decision Summary (RDS)

The regulatory decision summaries (RDSs) provide Canadians with an understanding of the decisions to approve or not approve the sale of drugs and medical devices in Canada.

RDSs for positive decisions issued after 01 April 2015, are provided for:

  • new drug submissions (NDSs) for prescription pharmaceuticals and biologics
  • supplemental new drug submissions (SNDSs) for new uses of prescription pharmaceuticals and biologics
  • new class IV licence applications for medical devices

Summaries are also posted for negative decisions and cancellations for NDSs accepted into review after 01 April 2015. These submissions are for drugs containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada.

The following RDSs for negative decisions and cancellations are now published as part of Phase II of the Transparency Initiatives for submissions accepted into review after 01 May 2016:

  • NDSs
  • SNDSs for new uses
  • new class IV licence applications for medical devices

The following information may be listed on the RDS:

  • What was the purpose of this submission?
  • Why was the decision issued?
  • What did the company submit to support its submission?
  • Decision issued
  • What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
  • Date of decision or cancellation
  • What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
  • Manufacturer
  • Drug Identification Number(s) if issued
  • Prescription status
  • Type of submission
  • Date filed
  • Control number

 

 

Links

Summary Under Review:

http://www.healthycanadians.gc.ca/drugs-products-medicaments-produits/authorizing-manufacturing-autorisation-fabrication/review-approvals-evaluation-approbations/submissions-under-review-presentations-cours-examen-eng.php

 

Regulatory Decision Summaries (RDSs), Medical Devices and Drugs: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/index-eng.php

 

Summary Basis of Decision (SBD), Medical Devices and Drugs: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/index-eng.php

 

 

 

Posted in Canadian Regulatory Affairs, Cato Research, Clinical Trials, Drug Development, Health Canada | Tagged , , | Comments Off on Transparency Initiatives at Health Canada

New FDA Guidances for October and November 2016

By Michelle Villasmil, Ph.D., Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in October and November 2016 are posted. In addition, upcoming advisory committee meetings to be held in the next month are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes – Final Guidance 29 Nov 2016
Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) – Final Guidance 28 Nov 2016
Submission of Quality Metrics Data Guidance for Industry – Draft Guidance 23 Nov 2016
Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions – Final Guidance 22 Nov 2016
Contract Manufacturing Arrangements for Drugs: Quality Agreements – Final Guidance 22 Nov 2016
Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data – Final Guidance 22 Nov 2016
Safety Testing of Drug Metabolites – Final Guidance 22 Nov 2016
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments – Final Guidance 21 Nov 2016
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices – Final Guidance 18 Nov 2016
BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment – Draft Guidance 17 Nov 2016
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices – Draft Guidance 10 Nov 2016
Medical Device Reporting for Manufacturers – Final Guidance 08 Nov 2016
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes – Final Guidance 07 Nov 2016
Non-Inferiority Clinical Trials – Final Guidance 07 Nov 2016
Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates – Final Guidance 01 Nov 2016
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 31 Oct 2016
Collection of Race and Ethnicity Data in Clinical Trials – Guidance for Industry and FDA Staff – Final Guidance 26 Oct 2016
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 25 Oct 2016
Software as a Medical Device (SaMD): Clinical Evaluation – Draft Guidance 14 Oct 2016
ANDA Submissions – Prior Approval Supplements Under GDUFA – Final Guidance 14 Oct 2016
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 11 Oct 2016
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 11 Oct 2016
Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry – Final Guidance 07 Oct 2016
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process – Final Guidance 07 Oct 2016
Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry – Final Guidance 05 Oct 2016
Tropical Disease Priority Review Vouchers – Final Guidance 05 Oct 2016
Acetaminophen; Oxycodone hydrochloride_204031 – Draft Guidance 04 Oct 2016
Upcoming Meetings (* = New)
* Bone, Reproductive and Urologic Drugs Advisory Committee; 06 December 2016; Silver Spring, MD
* 2017 Advisory Committee Tentative Meetings
* new entry

Last updated: 30 November 2016

 

 

Posted in Cato Research, Drug Development, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , | Comments Off on New FDA Guidances for October and November 2016