Jun 05 2017

New FDA Guidances for May 2017

By Sheila Plant, Ph.D., R.A.C., Assistant Director, Regulatory Strategy, US at Cato Research
One revised draft FDA guidance, released from CBER, and two MAPPs, released from CDER, in May 2017, are posted.  In addition, upcoming advisory committee meetings to be held in June and July are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Corrected Draft Guidance May 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
CDER FTE Tracking and Table of Organization Review Process 30 May 2017
Good Review Practice: Clinical and Consultative Review of Drugs to Reduce the Risk of Cancer 16 May 2017
Upcoming Meetings (* = New)
* June 20, 2017: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting
* June 21-22, 2017: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting
* July 28, 2017: Vaccines and Related Biological Products Advisory Committee Meeting
Last updated: 1 May 2017