Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and...
A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to addre...
FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.
Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions filed by drug companies ...
Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module 3 of the device for...
FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.
FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed to provide both geno...
FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with...
