OTC drug "lack of effect" postmarket reports should be dropped from FDA proposal -- J&J.
This article was originally published in The Tan Sheet
Executive Summary
OTC DRUG "LACK OF EFFECT" POSTMARKET REPORTS TO FDA should not be required under the agency's proposed adverse experience reporting procedures, Johnson & Johnson suggested in Jan. 24 comments to the agency. Responding to the agency's Oct. 27 proposed rule on adverse experience reporting, J&J recommended "the elimination of `lack of effect' reports, at least with regard to over-the-counter drugs, from the proposed requirements."