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The Federal Trade Commission is backing Mylan’s request for a rehearing before a panel of appellate judges on the dismissal of an antitrust lawsuit against Warner Chilcott and Mayne Pharmaceuticals. Read More
Industry is asking the FDA to impose stricter requirements for outsourcing facilities to qualify for an exemption that allows them to produce near replicas of approved products and compete with branded and generic drugs. Read More
Working groups representing both the generic and brand-name pharmaceutical industries told the FDA they need more guidance on how generic versions of abuse-deterrent opioid medications will be reviewed and approved. Read More
Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process. Read More
The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of introducing new priorities for this fiscal year — the final year of the five-year authorization for GDUFA I. Read More