FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders

FDA Commissioner Marty Makary recently communicated to industry CEOs that the agency is seeking more harmony between its Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), following recent leadership changes24.

Dr. George Tidmarsh, recently appointed head of CDER, will also temporarily lead CBER after the abrupt departure of Vinay Prasad, who resigned following controversy over his handling of cell and gene therapy approvals24.

Makary’s internal letter emphasized the need for stability and improved regulatory alignment between CBER and CDER, as Tidmarsh assumes dual leadership during the search for a permanent CBER director24.

CBER and CDER are collectively advancing guidance on accelerated approval pathways, especially for oncology and gene therapies, highlighting a broader goal of regulatory consistency and streamlined processes13.

FDA is explicitly focused on regulatory harmonization, with CBER taking part in international efforts to standardize technical guidelines and practices across agencies and product categories5.

Sources:

1. https://www.dlrcgroup.com/fda-guidance-radar-4-topics-to-watch-in-2025/

2. https://www.pharmaceutical-technology.com/news/george-tidmarsh-temporary-fda-cber-director/

3. https://www.cellandgene.com/doc/cell-gene-therapies-will-represent-a-continuation-of-fda-s-developments-0001

4. https://www.fiercepharma.com/pharma/fda-taps-newly-appointed-george-tidmarsh-cber-leader-after-prasad-exit

5. https://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence