FDA Finalizes Labeling Revision Rule; Similar To Controversial Proposal
This article was originally published in The Gray Sheet
Executive Summary
FDA is sticking with its plan to define when approved medical product labels can be changed without prior authorization from the agency
You may also be interested in...
Agencies Launch White House-Mandated Review Of Regulations
FDA and CMS announced preliminary plans May 26 for updating, streamlining or eliminating certain regulations in response to a White House request.
Agencies Launch White House-Mandated Review Of Regulations
FDA and CMS announced preliminary plans May 26 for updating, streamlining or eliminating certain regulations in response to a White House request.
PMA Supplement Guidance Finally Finalized, But Questions Remain
FDA finalized guidelines Dec. 11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.