FDA clears a Stimwave 510(k) for the StimQ Peripheral Nerve Stimulator System, a wireless, micro-technology neuromodulation device for treating chroni...
Mylan CEO Heather Bresch blames FDA reorganization for delays in approvals for two new generic drugs.
FDA accepts for priority review a Genentech supplemental NDA for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Federal Register notice: FDA makes available a draft guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Docume...
FDA warns Canadas Cellex-C drug manufacturing firm about significant CGMP violations.
FDA warns the Philippines Skin Sciences Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
FDA releases the FDA-483 issued following an inspection at Indias Biocon sterile drug manufacturer.
FDA announces a 9/18 public meeting to discuss topics related to the structured assessment of benefits and risks in drug regulatory decision-making.