Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug product regulation by con...
Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the generic device type: ...
FDA adds omicron updates to its Web page on viral mutations and their impact on Covid tests.
FDA issues draft guidances with clinical recommendations and chemistry, manufacturing, and controls recommendations for sponsors developing some antis...
The Natural Products Association says it is suing to force FDA to stop regulating N-acetyl-L-cysteine.
FDA warns Induction Therapies about marketing its Collagen P.I.N. microneedling product without agency approval.
The Senate Health, Education, Labor & Pensions Committee announces a 12/14 hearing on the nomination of Robert Califf to be the next FDA commissioner.
A Kleinfeld, Kaplan & Becker online post predicts that the prolonged Covid-19 pandemic will likely see the agency continue to adapt and utilize new st...