About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds

Nearly 5% of staff in the FDA's Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) have left following recent staff cuts by the Trump administration1.

The Department of Health and Human Services terminated 3,500 FDA employees on April 1, 2025, deeply affecting the offices that oversee drugs and biologics34.

Key roles lost in the layoffs include policy staff, project managers, scientists, and communications staff, all of whom are critical for agency operations3.

Industry experts, including a recently departed CBER director, have warned that these staff cuts threaten to upend drug review timelines and could jeopardize the FDA’s global regulatory leadership as early as 2026 or 20275.

FDA’s ability to issue guidance, provide application feedback, and predict approval dates may decrease, potentially resulting in slower product development and delayed drug approvals35.

Despite these challenges, remaining FDA review teams are reportedly still committed to meeting established review timelines for standard and priority applications5.

Sources:

1. https://endpts.com/about-5-of-cber-and-cder-left-after-fda-staff-cuts-analysis-finds/

3. https://www.skadden.com/insights/publications/2025/04/trump-administrations-first-100-days/mass-layoffs-at-fda

4. https://www.raps.org/news-and-articles/news-articles/2025/4/thousands-of-fda-staff-fired-in-latest-rif

5. https://www.fiercepharma.com/pharma/recently-departed-cber-director-warns-fda-staff-cuts-could-upend-drug-review-timelines-early