Experts Tout Rapid Vaccine Testing Method, USP Says More Data Needed

A pair of former Obama-era health experts want FDA to embrace a European Pharmacopoeia-approved vaccine screening method that could cut back the time it takes to test a vaccine for endotoxins from two weeks to five days, but the U.S. Pharmacopeia urges caution, and FDA says the drug industry already has flexibility to use the novel method. At issue is a synthetic reagent, known as recombinant factor C, that can detect endotoxins in drugs and vaccines. The experts say that...