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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 of the Pfizer-BioNTech COVID-19 vaccine. Read More
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 agency’s fiscal 2023 budget request. Read More
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 strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
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. Read More
The Department of Health and Human Services recommended that the product be kept available for an extra six months for possible use against new variants or subvariants that could become dominant in the U.S. Read More
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 journal Health Affairs. Read More
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. Read More
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. Read More
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 programs to the full House floor, one day after the Senate’s Health, Education, Labor and Pensions (HELP) Committee released its draft of the same legislation. Read More