Federal Register notice: FDA makes available a revised draft guidance entitled Assessing Adhesion With Transdermal and Topical Delivery Systems for AN...
Three Democratic senators led by presidential hopeful Elizabeth Warren raise concerns about CDRHs regulation of digital health devices and the Centers...
Members of the FDA Oncologic Drugs Advisory Committee vote unanimously to recommend approval of a Celltrion biosimilar to Biogens Rituxan for three ca...
FDA lifts a clinical hold against a CRISPR Therapeutics and Vertex Pharmaceuticals IND for CTX001 for treating sickle cell disease.
Biotechnology Innovation Organization submits comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demonstrating Effectivene...
FDA clears a Vapotherm 510(k) for its latest version of its Precision Flow Hi-VNI system, which includes a new product category and product code QAV.
Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling cha...