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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
The White House on Wednesday highlighted the administration’s ongoing efforts to rein in illegal fentanyl trafficking and unveiled a series of advisories to help businesses identify “red flags.” Read More
In a first for the UK’s Competition and Markets Authority (CMA), Aspen Pharma agreed to pay the National Health Service £8 million ($9.7 million) to settle anti-competition charges involving fludrocortisone acetate — an oral corticosteroid used to treat Addison’s disease and for other conditions. Read More
U.S. Sen. Gary Peters (D-Mich.) sent a letter Wednesday to acting FDA Commissioner Ned Sharpless asking what the agency is doing to curb drug shortages. Read More