FDA BIOLOGICS THREE-TIERED MANUFACTURING CHANGES CATEGORY SYSTEM BEING ADOPTED BY AGENCY; FDA REFORMS TOUTED BY CLINTON ADMINISTRATION IN PRE-EMPTIVE MOVE
Executive Summary
A three-tiered system for biologics manufacturing change reporting similar to that used for drug products is being implemented by FDA through a guideline that will issue "in a matter of days," FDA Deputy Commissioner for Policy William Schultz said at a March 16 trade press briefing.