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Nov 06 2015

New FDA Guidances for October 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in October 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation – Draft Guidance 29-Oct-2015
DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) – Final Guidance 28-Oct-2015
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route – Final Guidance 27-Oct-2015
Product Development Under the Animal Rule – Final Guidance 27-Oct-2015
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 26-Oct-2015
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance – Final Guidance 26-Oct-2015
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Draft Guidance 26-Oct-2015
Manufacturing Site Change Supplements: Content and Submission – Draft Guidance 21-Oct-2015
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use – Draft Guidance 21-Oct-2015
Draft PDEs for Triethylamine and for Methylisobutylketone – Draft Guidance 15-Oct-2015
ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents – Final Guidance 15-Oct-2015
General Considerations for Animal Studies for Medical Devices – Draft Guidance 14-Oct-2015
Recommendations for Microbial Vectors Used for Gene Therapy – Draft Guidance 14-Oct-2015
Integrated Summary of Effectiveness – Final Guidance 7-Oct-2015
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Final Guidance 7-Oct-2015
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval – Final Guidance 5-Oct-2015
M4E(R2): The CTD – Efficacy – Draft Guidance 1-Oct-2015
Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products – Draft Guidance 1-Oct-2015
Upcoming Meetings (* = New)
Science Advisory Board to the National Center for Toxicological Research, 03 and 04 November 2015; Jeferson, AR
Joint Meeting of the Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) and Drug Safety and Risk Management Advisory Committee, 05 November 2015; Silver Spring, MD
Anesthetic and Analgesic Drug Products Advisory Committee, 06 November 2015; Silver Spring, MD
Vaccines and Related Biological Products Advisory Committee, 13 November 2015; Silver Spring, MD
Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee, 18 November 2015; Silver Spring, MD
* Science Board to the FDA, 18 November 2015; Silver Spring, MD
* Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, 18-19 November 2015; Gaithersburg, MD
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, 19 November 2015; Silver Spring, MD
* Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, 24 November 2015; Silver Spring, MD
Psychopharmacologic Drugs Advisory Committee, 01 December 2015; Silver Spring, MD
Pulmonary-Allergy Drugs Advisory Committee, 09 December 2015; Silver Spring, MD
* Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and the Risk Management Advisory Committee, 10 December 2015; Silver Spring, MD
* new entry
Last updated: 02 November 2015