FDA Moves to Curb Drug Shortages
FDA Moves to Curb Drug Shortages
As required by the FDA Safety & Innovation Act (FDASIA) of 2012, FDA issued a Strategic Plan for responding to drug shortages Oct. 31, 2013, plus a proposed rule for how manufacturers should notify the agency of an interruption or discontinuation in production of a medically important therapy. The rule expands notification to a broader spectrum of drugs, including biologics, and advises on dealing with suppliers and contract manufacturers.
The Strategic Plan spells out how FDA can better respond to shortage situations and how manufacturers should avoid supply problems: build up inventories before making production changes, improve communications with contract manufacturers, and consider upgrades for aging facilities. There is support for incentives to companies that adopt manufacturing quality improvements and risk-based approaches, but few specifics on rewards for doing so.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
