The FDA received an official go-ahead from HHS on Thursday, setting into motion its planned reorganization of its inspection operations around the globe, with an extra focus on facility inspections, investigations and imports.
As part of the restructuring, which will begin Oct. 1, the Office of Regulatory Affairs, which previously housed all of the FDA’s drug and biologics inspectors, will now be called the Office of Inspections and Investigations (OII) to emphasize its “role as the frontline of the FDA,” according to an agency press release on Thursday.
Resources and laboratory safety foundations of the ORA will also be “realigned,” as stated in a draft document from HHS.
“I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” said FDA Commissioner Robert Califf in a statement.
The FDA originally announced its plans to “modernize” the agency back in December 2023.
As well as medical products, this new update encompasses the FDA’s regulation of food and agriculture products.
The OII will now function as a part of a new office — dubbed the Human Foods Program (HFP) — which will additionally house operations of the Center for Food Safety and Applied Nutrition, and the Office of Food Policy and Response. The impacted FDA departments are currently working on procedures to make a smooth transition into the HFP, and the changes will be effective by October 2024.