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...
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 plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...
FDA warns that the LyfeUnit Web site is selling unapproved adulterated and misbranded ketamine products.
FDA looks to formalize one of its most significant transparency initiatives in decades: the public release of Complete Response Letters issued to comp...
