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 Co...

The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...

The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...