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