The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current regulatory framework for pharmaceutical manufacturing in a new discussion paper.
The paper, which was jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on 1 March accompanies the agency’s release of the International Council on Harmonisation’s Q13 guideline on continuous manufacturing, which was adopted in November. (RELATED: ICH adopts Q13 guideline on continuous manufacturing, Regulatory Focus 5 December 2022)
FDA has been developing plans for incorporating AI into the medical device regulatory framework and is just beginning to look at how to apply these models in the pharmaceutical manufacturing space. (RELATED: FDA’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD, Regulatory Focus 18 January 2021)…
