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The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972. Read More
The House of Representatives approved the 21st Century Cures Act by a vote of 344 to 77 on July 10, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
The Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The European Commission says it does not have the authority to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
Lawmakers in the House introduced a bipartisan bill that would prevent brand drugmakers from thwarting competition by using restricted distribution networks to deny generics and biosimilars makers access to product samples they need to obtain FDA marketing approval. Read More