Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspections.
FDA releases the form FDA-483 with three observations from an inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX.
FDA grants Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephr...
FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyepti (eptinezumab-jjmr...
Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase complex deficiency, a r...
FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will cover FY 2028-2032.
Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could change the way that supp...
FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...
