FDA’s Five Year Plan: Advance Regulatory Science and Innovation - Level 3 Inspection

FDA’s Five Year Plan: Advance Regulatory Science and Innovation

The FDA recently unveiled its Strategic Priorities 2011-2015.
How will the next five years’ goals and objectives affect you?
First among the FDA’s newly redefined objectives is to strengthen regulatory science.  “Science underlies everything we do at this agency and to serve the public health we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies for the people who need them most,” says FDA Commissioner Margaret Hamburg.

Sophisticated informatics-based handling of clinical and engineering data will play a major role in the advancement of regulatory science.  With computer-aided inspection (CAI) you can satisfy regulators by recording and documenting every surface data point and every extracted dimension for future reference — while cutting iterations, months, and millions of dollars from the process development schedule.

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