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FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unapproved ophthalmic devices.[ Price : $8.95]
FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications...[ Price : $8.95]
FDA approves Johnson & Johnsons Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed fie...[ Price : $8.95]
Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical devic...[ Price : $8.95]
FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, rad...[ Price : $8.95]
FDA warns that the LyfeUnit Web site is selling unapproved adulterated and misbranded ketamine products.[ Price : $8.95]
FDA looks to formalize one of its most significant transparency initiatives in decades: the public release of Complete Response Le...[ Price : $8.95]
Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspecti...