In Brief: FDA journal reprints/textbook dissemination guidance
This article was originally published in The Tan Sheet
Executive Summary
FDA journal reprints/textbook dissemination guidance: Final guidance, published in the Oct. 8 Federal Register, remains virtually unchanged from the draft guidance issued last December. The agency says it reviewed over 57 comments on the draft and "determined that no changes need to be made." The guidance permits industry-sponsored dissemination of articles from peer-reviewed journals that describe efficacy studies used for agency approval...