Rep. Wyden's FDA reform bill would establish three categories of GMP changes.
This article was originally published in The Tan Sheet
Executive Summary
THREE CATEGORIES OF GMP CHANGES WOULD BE CREATED UNDER FDA REFORM BILL introduced by Rep. Ron Wyden (D-Ore.) on June 6. The primary intent of the section called "Rationalizing Good Manufacturing Practices" is to create three categories of manufacturing changes: (1) those that require FDA preclearance; (2) those that require a sponsor to notify FDA 30 days prior to implementation (for which no active approval is needed from the agency); and (3) those which require mention to FDA in annual reports.