Center for Drug Evaluation and Research
Coverage of Center for Drug Evaluation and Research in the Nexus archive.
- Opinion: STAT+: Dark times ahead at the FDA
FDA Commissioner Marty Makary was ousted along with Tracy Beth Høeg (CDER leader) and Katherine Szarama (CBER acting director), leaving three crucial FDA positions with only acting leadership. The simultaneous removal of these three high-ranking officials is characterized as an unprecedented ideological purge that has created significant instability within the agency.
- FDA’s top drug regulator ousted amid agency upheaval
Tracey Beth Høeg, the acting director of the FDA's Center for Drug Evaluation and Research, was ousted amid agency upheaval. She had served in the role since December and was the fifth head or acting head of the division. The move continues upheaval among the top ranks of the Food and Drug Administration.
- STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review
Sanofi has asked the FDA to pull its type 1 diabetes drug, teplizumab, out of a speedy drug review program after a dispute over the approval decision. The agency missed its goal date of April 21 to deliver a decision to Sanofi. The dispute involved acting Center for Drug Evaluation and Research director Tracy Beth Høeg.