Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical device facilities that ma...
FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing fac...
FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, ...
A Ropes & Gray legal update examines FDA initiatives to shorten drug development timelines and reduce regulatory burdens for sponsors.
Four stakeholders express varying opinions on the future direction and existence of the FDA national priority drug voucher program.
FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unapproved ophthalmic devices.
FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications while it evaluates ...
FDA approves Johnson & Johnsons Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed field and radiofrequenc...
