Federal Register notice: FDA announces a 3/15 virtual meeting entitled FDA Hiring and Retention Final Assessment and an opportunity for public comment...
Federal Register notice: FDA debars Brian Michael Parks for five years from importing or offering for import any article of food (including dietary su...
FDA takes issue with Denali Therapeutics preclinical toxicology assessment and requests changes to the clinical trial protocol, the informed consent f...
FDA accepts for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated locally advanced or meta...
CDERs Office of Generic Drugs says it approved 100-designated Competitive Generic Therapy ANDAs in 2021 for products recognized as lacking generic com...
A pivotal Phase 2-3 trial (Illuminate) evaluating ProQR Therapeutics sepofarsen for treating genetic eye disease CEP290-mediated Leber congenital amau...
FDA clears a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies.
FDA Review posts the Federal Register notices for the week ending 2/11/2022.