Regulatory Intelligence Brief: 2017 FDA Overview

All the major changes this year including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas not covered herein

By Meredith Brown-Tuttle, RAC, FRAPS, Principal Consultant, Regulatorium

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 Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry  Draft  06/30/2017 Administrative / Procedural  Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 –  Draft  06/20/2017  ICH-Quality  Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials.  Draft  02/17/2017  Administrative / Procedural  Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry  Final  02/16/2017  Administrative / Procedural Dear HealthCare Provider Letters: Improving Communication of Important Safety Information  Final  02/08/2017  Administrative / Procedural Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry & Review Staff  Draft  01/18/2017  Biosimilarity Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry  Draft  01/17/2017    2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry  Final  01/17/2017  Clinical - Medical  Assessment of Abuse Potential of Drugs  Final  01/17/2017  Compounding, Administrative / Procedural  Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Final  01/13/2017 Generic Drugs Referencing Approved Drug Products in ANDA Submissions Guidance for Industry Draft 01/13/2017 Generic Drugs Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry Draft 01/13/2017 Compounding, Administrative / Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Final 01/13/2017 Compliance, CGMP, Pharmaceutical Quality Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Final 01/12/2017 Generic Drugs Guidance for Industry 180-Day Exclusivity: Questions and Answers Draft 01/12/2017 Compliance, Pharmaceutical Quality, CGMP Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Draft 01/12/2017 Clinical - Medical Multiple Endpoints in Clinical Trials Guidance for Industry Draft 01/12/2017 Labeling Nonproprietary Naming of Biological Products Guidance for Industry Final 01/12/2017 Combination Products, CGMP Current Good Manufacturing Practice Requirements for Combination Products Final 1/10/2017 Q&A Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry   01/09/2017

 

 

 

 

 

 
Major Legislation/Regulations
What were the major legislation that was passed this year and will find their way to implementation through the passage of regulations or by other means enacted?

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