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Arbutus Biopharma and Genevant Sciences have filed a complaint in a federal court alleging that Pfizer and BioNTech violated five patents related to their messenger RNA (mRNA) delivery technology used in the Pfizer/BioNTech COVID-19 vaccine. Read More
The European Medicines Agency (EMA) is updating its Priority Medicines (PRIME) program to include new ways to track a product’s progress toward approval and to get more timely advice from the agency. Read More
Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the document, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar. Read More
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained her center’s top budget priorities for fiscal 2024 — highlighting steps to shore up the drug supply chain and improve generics availability — yesterday at an Alliance for a Stronger FDA webinar. Read More
In a move to help prevent or mitigate shortages, the FDA is asking drugmakers to provide more information regarding manufacturing disruptions that could affect finished drugs and biological products as well as some active pharmaceutical ingredients (API). Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
The FDA rapped Omega Packaging Corp with a nine-observation Form 483 following an inspection of its Totowa, N.J., facility for deficient test methods and other lapses in its manufacture of hand sanitizers. Read More
Teva Pharmaceuticals was given a three-observation Form 483 following an inspection of its Fairfield, N.J., finished product manufacturing firm for inadequately cleaned and maintained equipment and other lapses. Read More
The FDA handed Defender SD Manufacturing a five-observation Form 483 following an inspection of its San Diego, Calif., facility for a quality unit that lacked authority to investigate errors, lack of written production procedures and environmental monitoring deficiencies, among other lapses. Read More
The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls for its drug products, and other lapses. Read More
The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the product. Read More