Bipartisan House Energy and Commerce Committee ask FDA to provide information on the agencys approval performance on complex generic drugs, saying the...
TG Therapeutics begins a rolling NDA submission for umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously t...
Federal Register notice: FDA submits to OMB an information collection extension for BLA general licensing provisions.
CDRH electrical engineer Lowell Howard explains in a CDRH Learn video how manufacturers and importers can comply with the FDA electronic product radia...
FDA sets a 3/5 public workshop entitled Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine.
Mindbreeze says it is working with Booz Allen to give CDER regulatory review search capabilities.
FDA grants Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrope for treating decom...
FDA denies an Otsuka petition asking that it determine that the companys Samsca was withdrawn for reasons of safety and that no generic forms of the d...