The FDA’s director of drugs, Janet Woodcock, is pushing her manufacturing and product quality experts to “reinvigorate” her brainchild “GMPs (Good Manufacturing Practices) for 21st Century” initiative and move it to the next level.
“We’ve gotten a lot done on quality-by-design and our new review processes and so forth,” Woodcock said during a keynote address at an FDA/Temple University School of Pharmacy regulatory affairs conference.
“Industry is now stepping up to the plate, and we need to get to the next level, which would be to eliminate a lot of the manufacturing supplements because we have the appropriate quality-by-design information,” she said.
Last year at the Drug Information Association’s annual meeting, FDA Office of New Drug Quality Assessment postmarketing evaluation division director Eric Duffy said the agency was developing categories of low-risk post-approval changes where less oversight might be appropriate. This effort was part of the agency’s GMP initiative to develop a risk-based review paradigm to “downgrade” the filing categories for certain prior-approval supplements.
Also last year, the FDA held a public meeting on marketing application supplements where it received comments on how it could revise regulations to allow risk-based approaches based on manufacturing process understanding, and steps to reduce the number of supplements.
From the July 01, 2008 Issue of MM+M - Medical Marketing and Media
