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Allergan, along with Ironwood Pharmaceuticals, filed a suit against five generics companies, alleging infringement of nine patents covering its irritable bowel syndrome drug, Linzess. Read More
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. 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 generics sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Read More
The U.S. Supreme Court refused to hear appeals brought by Purdue Pharma LP for a patent infringement case centered on reformulations of the painkiller OxyContin, clearing several barriers to the development of generics. Read More
The development process for biosimilar blood thinners no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
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