FDA overhaul coming

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The FDA is getting an overhaul and it is going to include sub-specialty training for some employees. Regulatory Focus reported on an email that outlined the reorg initiative five months ago, and says Commissioner Margaret Hamburg has outlined steps that will upgrade the agency's skill sets to match industry demands.

Among the changes noted by RF:

  • Agency-wide alignment around pharmaceutical quality, medical devices, biological products, bioresearch monitoring and food/feed products.
  • Compliance officer specialization, when needed. Sub-specialization for some employees.
  • Reducing Office of Regulatory Affairs bureaucracy. One goal is to stop divvying things up by geography, and organize things by program or function instead.
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