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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
FDA Acting Commissioner Janet Woodcock said the FDA urgently needs to revamp its inspection program in testimony before the Senate Appropriations subcommittee on the agency’s fiscal 2022 budget request. Read More
Merck is withdrawing its accelerated approval application to the FDA for its blockbuster cancer drug Keytruda (pembrolizumab) for third-line treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, following disappointing study results. Read More
Prices for cancer drugs are higher when first introduced on the U.S. than in three wealthy European countries — Germany, Switzerland and England — and their prices tend to increase faster than inflation in the U.S. while decreasing in inflation-adjusted terms in the latter three nations, a new study found. Read More
Pharmaceutical companies, pharmacy benefits managers (PBMs) and hospitals are high on the target list of the Federal Trade Commission (FTC) as the agency moves to deepen its antitrust investigations into bad actors in certain industries over the next decade. Read More
The House Committee on Appropriations has advanced legislation to increase nonuser-fee funding to the FDA by $257 million to $3.45 billion in fiscal year 2022 and the fast-moving bill is on its way to the House floor with a vote expected in July — but there may be a few catches. Read More