FDA Official Urges Manufacturers to Take QbD Risks
As part of the FDA’s Quality by Design (QbD) initiative, the agency’s Chief Medical Officer Janet Woodcock is urging the industry to take risks associated with submitting QbD new drug applications in order to obtain regulatory flexibility in postapproval manufacturing submissions.
“The industry must change and in some ways you have to change first,” Woodcock said at a recent Parenteral Drug Association’s Quality by Design for Biopharmaceuticals conference.
Manufacturers are going to need to submit more information to the FDA for QbD applications so that the agency can get a good understanding for the variability of companies’ products, Woodcock said. Obtaining that understanding is necessary for the FDA to be convinced that certain postapproval manufacturing changes can be initiated without review and approval.
“Unless some people are willing to take risks and move into this area and make proposals, then it’s going to be difficult for the FDA. The FDA cannot do this unilaterally,” Woodcock said.
The agency plans to publish a guidance regarding QbD submissions as “as soon as we can,” according to Woodcock. In addition, the FDA is currently working on revising GMP regulations.