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Persion Pharmaceuticals has petitioned the FDA to ensure that generics of its Zohydro ER hydrocodone bitartrate extended-release capsules prove their bioequivalence in patients with hepatic impairment. Read More
Syneos called for “guidance on how product should be properly tapered or discontinued, particularly for long-acting opioids or those used for chronic pain.” Read More
A federal court in Massachusetts threw out a proposed class-action lawsuit by consumers against Actavis and Shire over pay-for-delay allegations but said direct buyers may still argue their case. Read More
Three former FDA commissioners unveiled a report on Thursday that proposes a dozen ways to expand the use of real-world evidence (RWE) and real-world data (RWD). Read More
The Trump administration has appealed a federal judge’s decision to shoot down a proposed HHS rule that would require direct-to-consumer TV ads to show the list price of drugs. Read More