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 ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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.
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