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Jan 04

New FDA Guidances for December 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in December are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Labeling of Red Blood Cell Units with Historical Antigen Typing Results – Final Guidance 20 Dec 2018
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data – Draft Guidance 20 Dec 2018
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics – Final Guidance 19 Dec 2018
Breakthrough Devices Program – Final Guidance 18 Dec 2018
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment – Draft Guidance 17 Dec 2018
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications – Final Guidance 12 Dec 2018
Data Integrity and Compliance With Current Good Manufacturing Practice – Final Guidance 12 Dec 2018
Biomarker Qualification: Evidentiary Framework – Draft Guidance 11 Dec 2018
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 – Draft Guidance 11 Dec 2018
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers – Draft Guidance 11 Dec 2018
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) – Draft Guidance 11 Dec 2018
Questions and Answers on Biosimilar Development and the BPCI Act – Final Guidance 11 Dec 2018
Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act – Draft Guidance 10 Dec 2018
Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion – Draft Guidance 04 Dec 2018
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA – Final Guidance 03 Dec 2018
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment – Final Guidance 03 Dec 2018
Upcoming Meetings (* = New)  
  January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
  January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  January 17, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* February 6-7, 2019: Tobacco Products Scientific Advisory Committee Meeting Announcement
* February 12, 2019: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Last updated: 31 December 2018