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Another lawmaker has joined the ranks of those calling for a federal investigation into an allegedly improper collaboration between FDA officials and Biogen to ensure approval of Aduhelm (aducanumab), the first new Alzheimer’s treatment in nearly 20 years. Read More
She has held several prominent positions within the agency, including lead negotiator with industry for the FDA’s commitments under the Generic Drug User Fee Act (GDUFA) III. Read More
Teva Pharmaceuticals has filed federal lawsuits against Aurobindo and Lupin over their planned generics of its Huntington’s disease drug Austedo (deutetrabenazine). Read More
On its long slog toward FDA approval, teplizumab, a monoclonal antibody being developed for delaying or preventing type 1 diabetes, has stumbled over bioequivalency concerns. Read More
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations. Read More
The FDA details its latest procedures for evaluating color additives or flavors added to a new oral drug in a new manual for the agency’s staff. Read More
The FDA is prioritizing preapproval inspections of generics based on whether the products can alleviate drug shortages, agency officials said at the Drug Information Association (DIA)’s 2021 global annual meeting. Read More
A third-party investigation of Eli Lilly’s Branchburg, N.J., facility, the site of internal whistleblower claims alleging that a quality official tampered with findings, has concluded that there is no evidence of wrongdoing at the plant. Read More
The Biden administration released a belated spring regulatory agenda that includes the following proposed rules in order of when the FDA expects to take action: Read More
With a Drug Supply Chain Security Act (DSCSA) implementation date set for 2023, the FDA has published four guidances designed to bolster efforts to identify and trace drugs as they move through the supply chain, including a final guidance clarifying product identifier requirements for drugmakers. Read More