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Article: 'Answer-based Submissions' touted for working with CDER's 'Question-based Review' for generics.(CMC/Design space)
- Article from:
- Validation Times
- Article date:
- May 1, 2006
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Generic drug makers seeking ways to fathom FDA's new "Question-based Review" (QbR) of ANDAs should consider a concept that one executive is calling "Answer-based Submissions" as a means of providing a good "quality overall summary" (QOS) and achieving "design space," both of which are important facets of the agency's four-year-old drug quality initiative.
Dhiren Shah, Ph.D., head of regulatory affairs for Martec USA, Kansas City, MO., told a May 16 Expertbriefings.com audioconference that QbR is a "tool for development of mechanistic understanding-based specifications (design space)."
He defended FDA's approach, saying it will "increase product quality ...