FDA Seeks Streamlined, More Effective GMP Inspections

The US Food and Drug Administration plans to shut down its regional offices and some additional field facilities, a move that reflects an ever-tightening squeeze on agency funding and staff. FDA also seeks to make more efficient use of its limited resources by establishing risk-based approaches for selecting those drug-manufacturing sites most in need of frequent oversight, while reducing inspections for less risky facilities. More highly trained inspectors will be able to assess modern manufacturing systems with greater efficiency, and field staff will collaborate better with reviewers in FDA Centers to understand company quality-control systems better.

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