New FDA Guidances for February 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 February 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials – Draft Guidance 17 Feb 2017
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy – Final Guidance 16 Feb 2017
Guidance Agenda: Guidances CDER is Planning… – Draft Guidance 15 Feb 2017
Dear Health Care Provider Letters: Improving Communication of Important Safety Information – Final Guidance 08 Feb 2017
Upcoming Meetings (* = New)
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; Silver Spring, 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
* Blood Products Advisory Committee Meeting; 4-5 April 2017; Silver Spring, MD
2017 Advisory Committee Tentative Meetings
* new entry
Last updated: 01 March 2017
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