FDA promotes new drug-making technologies

Medical Marketing and Media, May 2002 by Dickinson, James G

Recognizing that some drug companies have introduced new manufacturing technologies in their facilities in Germany and Australia but not in the United States, presumably because of concerns about the regulatory environment, the FDA has decided to assume the leadership role in facilitating the introduction of process analytical technology (PAT) here.

A subcommittee of the FDA's Advisory Committee on Pharmaceutical Science has been working on the issue since late last year, and in March, FDA drugs director Janet Woodcock presented the effort at the 26th GMP Conference. The initiative the FDA is pursuing involves use of a number of types of at-line or online sensors to monitor and/or control process or product attributes, Woodcock said.