Boehringer and Lon­za ques­tion the fu­ture of FDA's reg­u­la­tion of AI in man­u­fac­tur­ing

The FDA opened the floor for com­ments on its dis­cus­sion pa­per on the use of AI in drug man­u­fac­tur­ing, with in­ter­est groups and man­u­fac­tur­ers in the US and Eu­rope sub­mit­ting tweaks to the agency.

The dis­cus­sion pa­per on AI in drug man­u­fac­tur­ing fo­cused on is­sues like cloud ap­pli­ca­tions for da­ta, the need for more clar­i­ty about how AI is sub­ject to reg­u­la­to­ry over­sight, and the need for val­i­dat­ing AI mod­els.

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