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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
“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patients who can’t respond adequately to vaccination alone,” said Iskra Reic, AstraZeneca’s executive vice president for vaccines and immune therapies. Read More
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investigating out-of-specification (OOS) drug test results, adding recommendations for evaluating results and revising outdated terminology. Read More
The FDA formalized user fee assessment changes under the Generic Drug User Fee Act of 2017 (GDUFA) in a final guidance released yesterday, adding a new section on refunds to sponsors. Read More