Orphan Drugs Warrant Flexibility On Clinical Pharmacology Data, FDA Panel Says
FDA should use its regulatory flexibility to require fewer pre-approval clinical pharmacology studies, with increased emphasis on post-marketing studies and mandatory registries, to speed development of orphan drugs, the agency’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology said.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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