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Aug 18

New FDA Guidances for July 2016

By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, 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
General Wellness: Policy for Low Risk Devices – Final Guidance 7/29/2016
Adaptive Designs for Medical Device Clinical Studies – Final Guidance 7/27/2016
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices – Draft Guidance 7/27/2016
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) – Draft Guidance 7/26/2016
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) – Final Guidance 7/18/2016
E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers – Final Guidance 7/18/2016
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma – Final Guidance 7/17/2016
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product – Draft Guidance 7/15/2016
Bacterial Vaginosis: Developing Drugs for Treatment – Draft Guidance 7/13/2016
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices – Final Guidance 7/11/2016
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics – Draft Guidance 7/8/2016
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn – Draft Guidance 7/8/2016
Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases – Draft Guidance 7/8/2016
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 7/7/2016
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 7/7/2016
Upcoming Meetings (* = New)
* Cellular, Tissue, and Gene Therapies Advisory Committee Meeting; 07 September 2016, Silver Spring, MD
* Oncologic Drugs Advisory Committee Meeting Announcement; 14 September 2016, Silver Spring, MD
* Pediatric Advisory Committee Meeting; 14 September 2016, Bethesda, MD
* National Mammography Quality Assurance Advisory Committee Meeting; 15 September 2016, Gaithersburg, MD
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee Meeting, 15-16 September, Silver Spring, MD
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee – 19 October, Silver Spring, MD
* new entry
Last updated: 17 August 2016