May 08 2017

New FDA Guidances for March and April 2017

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH, and Manual of Policies and Procedures (MAPPs) of interest, released from CDER in March and April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles – Draft Guidance 24 Apr 2017
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Final Guidance 07 Apr 2017
Delayed Graft Function in Kidney Transplant: Developing Drugs for Prevention: Guidance for Industry – Draft Guidance 22 Mar 2017
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Expiration date, updated) – Final Guidance 14 Mar 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health 06 Mar 2017
Upcoming Meetings (* = New)
* May 17, 2017: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* May 17, 2017: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* May 24, 2017: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
* May 25, 2017: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
2017 Advisory Committee Tentative Meetings