FDA, EMA Joint Assessment of QbD Review Pilot Offers Filing Advice

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