FDA releases the FDA-483 with two observations from an inspection at Indias Biocon Limited.
FDA qualifies a software module to help develop medical devices to treat traumatic brain injury.
FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis wh...
FDA sends an Integra LifeSciences a Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility.
Federal Register notice: FDA is seeking comments on an information collection entitled Export of Medical Devices; Foreign Letters of Approval.
Federal Register notice: FDA seeks comments on an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Federal Register notice: FDA makes available a model Drug Facts label for nonprescription naloxone, indicated for treating opioid overdose.