A collection of 24 states is displaying its support to the Department of Health and Human Services (HHS) in its legal fight with several drugmakers over access to drugs discounted…
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices voted yesterday to recommend that children between the ages of five and 11 should receive booster doses…
FDA Commissioner Robert Califf announced a new role for agency veteran Janet Woodcock in his remarks at a House subcommittee hearing yesterday, where he was slated to speak on the…
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment…
A federal court has thrown out a rule that forced pharma companies to include discounts they offer to patients when calculating the so-called best price for Medicaid’s drug rebate program.…
Pharmaceutical manufacturers are playing something of a shell game with inhalers, maintaining their patents and market exclusivity with new products that aren’t really new, according to research reported in the…
The FDA’s novel drug approvals continued to be supported by fewer, less rigorous and more flexible pivotal trials as well as surrogate endpoints in 2020, a new analysis has found.…
A final guidance on product labeling released by the FDA yesterday focuses on label designs that promote safe dispensing and use and help minimize medication errors. Source: Drug Industry Daily
The House Energy and Commerce Committee voted unanimously Wednesday to move its version of a bill to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device user fee…
The FDA has revised its final guidance on investigating out-of-specification (OOS) drug test results, adding recommendations for evaluating results and revising outdated terminology. Source: Drug Industry Daily