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Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program. Read More
NDAs and ANDAs claiming to contain a co-crystal form should include evidence demonstrating both the coformers and the API are present in the unit cell, the agency said. Read More
The Philadelphia District Attorney is suing opioid manufacturers and is the first to sue under Pennsylvania’s consumer protection law — making it a public enforcement action on behalf of all Philadelphia residents. Read More
The FDA denied a petition seeking the withdrawal of the AMAG Pharmaceuticals hormone drug Makena (hydroxyprogesterone caproate), which a patients’ rights group argues has possible links to developmental abnormalities. Read More
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two EU proposals the groups say could hurt patent rights. Read More
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More