FDA Releases Five-Year Strategic Priorities

The FDA released the 50-page Strategic Priorities 2011 - 2015: Responding to the Public Health Challenges of the 21st Century.

The FDA recently released the 50-page Strategic Priorities 2011 - 2015: Responding to the Public Health Challenges of the 21st Century. The document identifies five "cross-cutting areas," including regulatory science. The remaining four target safety in the global supply chain; stronger compliance and enforcement activities; greater attention to such special populations as women, minorities and children; and emergency medical countermeasures.

Regarding compliance and enforcement, the document recaps recent FDA changes, including deadlines for warning letter responses and the means to prioritize post-warning-letter/post-recall follow-up plant inspections. New programs will "sharpen the effectiveness and timeliness of regulatory, compliance and enforcement systems."