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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 generics sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Read More
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 from drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
The FDA rejected Adapt Pharma’s request to raise the standards for the approval of naloxone generics, arguing that products will be reviewed on a case by case basis. Read More
To ensure consistency, CDER has established procedures and policies for staff to receive clearance to participate in public-private partnerships. Read More
The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Read More
The FDA finalized guidance yesterday on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency, trading partners and wholesale distributors. Read More