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Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance 18 Jan 2017
Considerations in Demonstrating Interchangeability With a Reference Product – Draft Guidance 17 Jan 2017
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers – Draft Guidance 17 Jan 2017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How to Prepare a Pre-Request for Designation (Pre-RFD) – Draft Guidance 13 Jan 2017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Referencing Approved Drug Products in ANDA Submissions – Draft Guidance 13 Jan 2017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and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA – Draft Guidance 13 Jan 2017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Guidance for Industry 180-Day Exclusivity: Questions and Answers – Draft Guidance 12 Jan 2017
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Draft Guidance 12 Jan 2017
Multiple Endpoints in Clinical Trials – Draft Guidance 12 Jan 2017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