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As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable. Read More
An industry group has updated its pharmaceutical supply chain management guideline, implementing the latest changes in data standards ahead of federal standards mandating the ability to track and trace individual drug products. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
The FDA has updated final guidance on safety testing for drug metabolites to conform to the ICH’s latest standards on toxicity detection and testing. Read More
The FDA approved two rival therapies for type 2 diabetes on the same day — Sanofi’s Soliqua and Novo Nordisk’s Xultophy — following a long race to produce the next blockbuster drug. Read More