Behind-The-Counter Sale Works Without Regulation – Former FDA Counsel
This article was originally published in The Tan Sheet
FDA's interest in establishing an official third class of drugs, as well as the OTC industry's concern about the idea, could be diminished because the agency already allows a path to behind-the-counter sales in new drug and switch applications, according to a former FDA chief counsel
You may also be interested in...
Behind-the-counter status does not diminish customers' loyalty to brand name nonprescription drugs, according to results of a nationwide survey
FDA and industry should immediately begin pursuing the development of a regulatory process for a behind-the-counter class of drugs, FDA Commissioner Andrew C. von Eschenbach, M.D., told OTC industry executives March 16
FDA's approved labeling for GlaxoSmithKline's first-in-class nonprescription weight-loss drug alli (orlistat 60 mg) emphasizes a "goal oriented" indication as opposed to a six-month duration of use as originally proposed