«

»

Sep 12

New FDA Guidances for August 2016

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in August 2016, are posted. One recent CDER Manual of Policies and Procedures (MAPP) regarding a change in hard gelatin capsule shell suppliers is included.  In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices – Final Guidance 30 Aug 2016
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components – Final Guidance 26 Aug 2016
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications – Final Guidance 24 Aug 2016
Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling – Final Guidance 24 Aug 2016
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation – Final Guidance 24 Aug 2016
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits – Final Guidance 24 Aug 2016
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products – Final Guidance 17 Aug 2016
Regulatory Classification of Pharmaceutical Co-Crystals – Draft Guidance 16 Aug 2016
Change in Hard Gelatin Capsule Shell Supplier – CDER MAPP 15 Aug 2016
Deciding When to Submit a 510(k) for a Change to an Existing Device – Draft Guidance 08 Aug 2016
Deciding When to Submit a 510(k) for a Software Change to an Existing Device – Draft Guidance 08 Aug 2016
Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry – Draft Guidance 05 Aug 2016
Insanitary Conditions at Compounding Facilities Guidance for Industry – Draft Guidance 03 Aug 2016
Medical X-Ray Imaging Devices Conformance with IEC Standards – Draft Guidance 03 Aug 2016
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use – Compliance Policy – Final Guidance 02 Aug 2016
FY 2017 Medical Device User Fee Small Business Qualification and Certification – Guidance for Industry, Food and Drug Administration Staff and Foreign Governments – Final Guidance 01 Aug 2016
Upcoming Meetings (* = New)
 
Oncologic Drugs Advisory Committee Meeting; 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
 

*

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; 15 September 2016, Silver Spring, MD
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee – 19 October 2016, Silver Spring, MD
 

*

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, Establishment of a Public Docket, Request for Comments; 20-21 September 2016, Gaithersburg, MD
 

*

Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting; 5 October 2016, Gaithersburg, MD
* Vaccines and Related Biological Products Advisory Committee Meeting; 13 October 2016, Silver Spring, MD
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee – 19 October, Silver Spring, MD
* Allergenic Products Advisory Committee Meeting; 27 October 2016, Silver Spring, MD
* new entry

Last updated: 06 September 2016