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 companies whose drug applications are rejected.
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 companies whose drug applications are rejected.
Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspections.
FDA releases the form FDA-483 with three observations from an inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX.
