Enforcement, Supply Chain Issues Are Key Items in FDA Work Plan

Tougher enforcement, pediatric devices and global supply chain issues are among the FDA’s top priorities for the next five years as the agency seeks to advance initiatives implemented since Margaret Hamburg became commissioner.

The agency plans to make follow-up inspections a priority after a devicemaker has had a significant enforcement action, such as a warning letter or a major recall. The agency also wants to bolster its relationship with foreign regulatory and enforcement partners that may be able to act more quickly in some cases, according to its five-year work plan.

As for pediatric devices, the agency is specifically looking to develop validated endpoints for neonate products. It also wants to explore why so many products that work in adults apparently do not work in children.
The GMP Letter