FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potenc...
Staff from FDA and several drug companies use a Journal of Regulatory Affairs article to explain a 2024 FDA guidance on optimizing EDDO control strate...
A new report by CDERs Office of Clinical Pharmacology says regulatory science will have to evolve alongside increasingly complex therapies, with great...
FDAs proposed drug user fee commitments could give drug and biologics sponsors several new opportunities to address manufacturing facility problems be...
FDA begins next month accepting requests from drug and biologics sponsors seeking to participate in the fifth and final year of its Chemistry, Manufac...
A bipartisan Senate bill intended to give patients and health care providers more information about where prescription drugs are manufactured loses tw...
HHS secretary Robert F. Kennedy Jr.'s vaccine skepticism remarks this week likely complicate Heidi Overtons upcoming confirmation hearing to lead FDA....
FDA grants Eli Lilly full approval for the combination use of Inluriyo (imlunestrant) with Verzenio (abemaciclib) in certain adults with estrogen rece...
