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Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspecti...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX...[ Price : $8.95]
FDA grants Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary im...[ Price : $8.95]
FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyep...[ Price : $8.95]
Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase com...[ Price : $8.95]
FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will co...[ Price : $8.95]
FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, rad...[ Price : $8.95]
Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could chan...