FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.
MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements on manufacturers.
FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medical devices.
FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulnerabilities in a Black...
FDA approves an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who are at risk of ischemi...
Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for five narcotic drugs.
CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled contract manufacturing f...
Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.