Business · 27/06/19971 min read

FDA Proposes Changes to Pre-Market Approval Application Announcement Procedures

The Food and Drug Administration (FDA) is proposing to revise its announcement procedures for pre-market approval applications (PMA), aiming to expedite the availability of information by discontinuing print publication in the Federal Register and announcing approvals and denials online, with summaries of safety and effectiveness also available through the Internet and in FDA's Dockets Management Branch.