What's New at CBER

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What's New Today

The following links have been updated recently:

Posted: 09/19/2023

• Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry

Register Now! 2023 PDA/ FDA Joint Regulatory Conference September 18 - 20, 2023

Call for Submissions!

Rare Disease Endpoint Advancement Pilot Program

FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Meeting Program is accepting RDEA proposals for this quarter until September 30, 2023. The RDEA Pilot Meeting Program is designed to support novel endpoint efficacy development for drugs that treat rare diseases by providing a mechanism for sponsors to collaborate with FDA throughout the efficacy endpoint development process. The RDEA Pilot Meeting Program provides an opportunity for sponsors whose proposals are admitted to the program to interact with FDA experts at up to four meetings designed specifically to discuss their proposed novel endpoint. 

RDEA proposals may be submitted on a rolling basis and must be received by the last calendar day of each quarter.

Quarterly proposal submission deadlines: 

• March 31
• June 30
• September 30
• December 31

For more information about the program and how to submit an RDEA proposal, please see the recently updated RDEA Pilot Program webpage and the RDEA Pilot Program Frequently Asked Questions webpage.

Upcoming CBER Meetings

September Cellular, Tissue, and Gene Therapies Advisory Committee Meeting September 27, 2023

October 2023 Warrior Families Webinar October 5, 2023 Vaccines and Related Biological Products Advisory Committee Meeting October 5, 2023 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting October 31, 2023

November Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards November 7, 2023