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Home » FDA Says QbD Needs CMC Postapproval Management Plans
FDA Says QbD Needs CMC Postapproval Management Plans
July 11, 2008
The quality-by-design (QbD) pilot program for small molecules is a success and it is moving well into the implementation stages, but some of the outstanding questions about the data necessary to support broad design spaces still need to be addressed, according to the FDA.