The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent ...
Green Matters on MSN
FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose
Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration ...
WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to ...
The Food and Drug Administration is recalling 16 brands of cinnamon that contain elevated lead levels, which over time can cause neurological problems including learning disabilities in young children ...
Peter Marks, M.D., Ph.D., the former head of the FDA’s Center for Biologics Evaluation and Research (CBER), has joined Eli Lilly as senior vice president of molecule discovery and head of infectious ...
The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs used to treat menopause symptoms, a move many experts say is long overdue.
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