- After a slowdown in FDA inspections during the first quarter of 2025 and the mass departure of over 3,500 employees, FDA is pivoting to state authority and generative AI technology to help the agency “do more with less.” FDA currently has contracts with forty-three states and plans to expand this program to have more states conduct FDA inspections of food and beverage facilities.
- Following the shift in responsibility, food and drug manufacturers have recently seen an uptick in inspection notices. Foreign facilities are experiencing more unannounced inspections as FDA seeks to treat foreign firms like domestic firms with less lead time before inspections, as we previously blogged.
- FDA Commissioner Marty Makary has also directed FDA centers to begin using AI for premarket scientific reviews, giving the agency an “aggressive timeline” of full integration by June 30, 2025. Makary claims that the use of AI will reduce the amount of “non-productive busywork” that consumes a large part of the scientific review process.
- FDA has announced that they will be releasing additional details about the use of AI later in June. Keller and Heckman will continue to report on these developments.
FDA Shifts Inspections to States and AI to Help Boost Efficiency
