FDA turns up the pressure on iRhythm Technologies based on a second Form FDA-483 issued last month at the companys Cypress, CA manufacturing facility ...
FDA accepts for priority review a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide), for treating obesity due to Bardet-Biedl syndr...
Public Citizens Health Research Group calls on HHS Office of Inspector General to investigate allegations that retiring CDRH director Jeff Shuren fail...
CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facilities where biologics...
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among ...
FDA clears a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit.
Inari Medical begins a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adverse events caused w...
