In Brief: PMA summary availability
This article was originally published in The Gray Sheet
Executive Summary
PMA summary availability: FDA proposes posting approvals, denials and summaries of safety and effectiveness data for premarket approval applications on its Internet home page and discontinuing their publication in the Federal Register. FDA explains that the proposal, published in the June 27 Federal Register, "would expedite public notification of these actions" and make the information more accessible. FDA is also proposing to publish quarterly lists of PMA approvals and denials in the Federal Register. Comments on the proposed rule are due by Sept. 25...