HHS Secretary Alex Azar offered more details on Monday of a plan that could expand Medicare’s ability to negotiate prices, implicitly responding to claims that the administration’s new drug pricing…
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Source: Drug…
The Department of Justice filed civil complaints in Florida and California to stop two companies offering unapproved stem cell treatments. Source: Drug Industry Daily
Tennessee became just the second state to legalize off-label promotion of drugs, a move drawing praise and some concern from experts. Source: Drug Industry Daily
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studies in adults and enroll clinical trial subjects in cohorts based on weight rather than age, according to new FDA draft guidance.…
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…
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…
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…
An FDA advisory committee voted 12 to 8 Thursday that Akcea Therapeutics’ NDA for treatment of a rare genetic disease demonstrated safety and efficacy. Source: Drug Industry Daily
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…