MedCity News April 2, 2025
As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agency’s ability to review and potentially approve such treatments.
Thousands of FDA workers lost their jobs this week. The most prominent was Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). While this position has been described as the FDA’s top vaccine official, it became much more under Marks.
Marks was appointed leader of CBER in 2016 and his tenure came alongside the emergence of new therapeutic modalities, such as cell and gene therapies. To some, he was a champion of new ways to treat diseases, particularly...
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