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Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to res...[ Price : $8.95]
A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISP...[ Price : $8.95]
FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.[ Price : $8.95]
Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions file...[ Price : $8.95]
Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module...[ Price : $8.95]
FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.[ Price : $8.95]
FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...[ Price : $8.95]
FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...