What's New at CBER

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What's New Today

The following links have been updated recently:

Posted: 6/12/2024

• OTP Town Hall: CMC Readiness for Gene Therapy BLAs
  Updated to include the June 2024 recording.
• June 11, 2024 Approval Letter - VAXCHORA
• CBER Title 21 Vacancy Announcement - Science Disclosure Analyst, AD-0401-Bands A/B, Office of Communication, Outreach and Development (OCOD), Division of Disclosure and Oversight Management (DDOM)

Guidance for Industry

Draft Guidance Documents for Industry – Submit Public Comments by July 29, 2024

• Considerations for the Use of Human and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
• Platform Technology Designation Program for Drug Development

RDEA Pilot Program

CBER and the Center for Drug Evaluation and Research (CDER) began accepting submissions to the Rare Disease Endpoint Advancement (RDEA) Pilot Program in September 2023. This innovative Pilot aims to accelerate rare disease drug development by fostering collaboration between sponsors and the FDA throughout the novel efficacy endpoint development process.

The FDA welcomes RDEA submissions on a quarterly basis, with up to one eligible proposal selected per quarter. The deadline for submitting applications this quarter is June 30, 2024.

For more information about the Program, visit Rare Disease Endpoint Advancement Pilot Program. Additionally, for guidance on submitting proposals to CBER, visit Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program.

If you would like to connect with the FDA RDEA team, please email RDEA.Meetings@fda.hhs.gov.