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Sponsors of pediatric HIV drugs should conduct bioequivalence studies in adults and enroll clinical trial subjects in cohorts based on weight rather than age, according to new FDA draft guidance. Read More
In a long-anticipated speech on drug pricing, President Trump announced reforms that “will bring soaring drug prices back down to earth,” but he cited few specifics and appeared to back off from a campaign promise to fight for Medicare to directly negotiate prescription prices. Read More
“[We] need to ensure that our ports are adequately staffed and equipped to deal with this problem—and right now that’s simply not the case,” said Sen. Claire McCaskill (D-Mo.). Read More
U.S. officials seized more than 12 tons of illicit opioids at ports of entry between 2013 and 2017, according to a new report that bolsters FDA Commissioner Scott Gottlieb’s call for more international mail facility staff to stem the addiction epidemic. Read More
Orphan drug development takes 18 percent longer to reach the product launch stage than new drugs across the board, according to a new analysis from the Tufts Center for the Study of Drug Development. Read More
An FDA advisory committee voted 12 to 8 Thursday that Akcea Therapeutics’ NDA for treatment of a rare genetic disease demonstrated safety and efficacy. Read More
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More