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Home » FDA, EMA Joint Assessment of QbD Review Pilot Offers Filing Advice
FDA, EMA Joint Assessment of QbD Review Pilot Offers Filing Advice
August 22, 2013
The FDA and European Medicines Agency (EMA) Tuesday released a joint assessment of their quality-by-design (QbD) pilot, which involves parallel reviews of NDAs with QbD components. Lauding the pilot as another useful regulatory team-up, the Q&A-style assessment includes a number of “lessons learnt,” including that critical quality attributes for a drug substance should always be classified as critical rather than broken down into tiered degrees of criticality.
Drug Industry Daily
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