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Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, becoming another Indian facility to get a warning letter for data integrity violations. Read More
Five Industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Tuesday, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
The FTC is demanding Cephalon pay as much as $4 billion as punishment for profiting illegally from pay-for-delay deals that put off generic versions of the company’s wakefulness drug Provigil from 2006 to 2012. Read More