Jul 10 2017

New FDA Guidances for June 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory 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 June 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.


Special Interest Guidances/Information Date Posted
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry – Draft Guidance 30 June 2017
Current Good Manufacturing Practice for Medical Gases – Draft Guidance 28 June 2017
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Final Guidance 27 June 2017
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Draft Guidance 20 June 2017
ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions – Draft Guidance 19 June 2017
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) – Revision 13 June 2017
Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions – Final Guidance 07 June 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Acceptance Criteria for Residual Solvents 28 June 2017
Prioritization of the Review of Original ANDAs, Amendments, and Supplements 27 June 2017
Review of Bioequivalence Studies with Clinical Endpoints in ANDAs 22 June 2017
NDAs/BLAs: Financial Disclosure  21 June 2017
Upcoming Meetings (* = New)
* July 11, 2017: Meeting of the Oncologic Drugs Advisory Committee
* July 12, 2017: Meeting of the Oncologic Drugs Advisory Committee
* July 13, 2017: Meeting of the Oncologic Drugs Advisory Committee
  July 28, 2017: Vaccines and Related Biological Products Advisory Committee Meeting
* August 2, 2017: Meeting of the Arthritis Advisory Committee Meeting
Last updated: 3 July 2017