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Emergent BioSolutions was hit with a potential class-action lawsuit on Wednesday, alleging the company made false and misleading statements regarding its manufacturing capabilities and quality control processes at its Bayview facility in Baltimore, Md. 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
Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. 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
Drug safety surveillance, which saw a massive workload increase at the FDA’s Center for Drug Evaluation and Research (CDER) during the pandemic, hopes to pick up additional funding in the fiscal 2022 budget, said recently appointed center director Patrizia Cavazzoni. Read More
The FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). Read More