FDA Databases for Post-Approval Requirements
WHAT: Database for oversight and tracking Studies, Requirements and Commitments postapproval.
WHY: Need for oversight. Drug studies, mandated as condition of approval (accelerated approval) or for improving prescribing and use, quality and consistency. Device studies mandated as condition of approval (PMA, PDP. HDE) and to ensure well-designed post-approval studies conducted effectively and efficiently..
HOW: Publicly accessible database. Updated regularly