FDA BACPAC -1 Draft Guidance Uses Decision-Tree Approach
This article was originally published in The Tan Sheet
Executive Summary
FDA's Bulk Active Post-Approval Changes draft guidance (BACPAC -1) incorporates a decision-tree approach in which the determination of the filing and testing requirements rests on an evaluation process rather than fixed standards used in FDA's Scale-Up & Post-Approval Changes (SUPAC) guidance.