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Apr 13

New FDA Guidances for February and March 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research

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

 

Special Interest Guidances/Information Date Posted
Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry – Final Guidance 26 Mar 2018
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Draft Guidance 23 Mar 2018
Postmarketing Safety Reporting for Combination Products – Draft Guidance 21 Mar 2018
M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk – Final Guidance 13 Mar 2018
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry – Draft Guidance 02 Mar 2018
E18 Genomic Sampling and Management of Genomic Data Guidance for Industry – Final Guidance 01 Mar 2018
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry – Draft Guidance 28 Feb 2018
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry – Draft Guidance 28 Feb 2018
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) – Final Guidance 28 Feb 2018
Q11 Development and Manufacture of Drug Substances–Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) – Final Guidance 23 Feb 2018
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions; Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 Feb 2018
Migraine: Developing Drugs for Acute Treatment – Final Guidance 15 Feb 2018
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry – Final Guidance 15 Feb 2018
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment – Draft Guidance 15 Feb 2018
Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy – Draft Guidance 15 Feb 2018
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older – Draft Guidance 15 Feb 2018
Regulatory Classification of Pharmaceutical Co-Crystals – Revised Final Guidance 14 Feb 2018
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry – Final Guidance 12 Feb 2018
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation – Final Guidance 07 Feb 2018
Upcoming Meetings (* = New)
* May 2, 2018: Antimicrobial Drugs Advisory Committee Meeting Announcement
* May 3, 2018: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Announcement
* May 10, 2018: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* May 22, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* April 19, 2018: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
* April 23, 2018: Arthritis Advisory Committee Meeting
* April 24-25, 2018: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Last updated: 05 April 2018