This article was originally published in The Gold Sheet
...is leading to a clearer concept of the substance and role of the regulatory agreement as a key element in structuring a more flexible quality regulatory system. Industry participants in FDA’s CMC pilot program have been proposing regulatory agreements, and FDA has begun drafting guidance based on the experience gained. The CMC pilots and agency/industry dialogue at public forums are also helping to shed light on a variety of other outstanding issues concerning how QbD should be built into the pharmaceutical development, validation and approval processes. In the generics arena, the question-based review initiative is gaining traction, and industry is looking for more feedback to help refine the process. Ways to spur biotech QbD and international harmonization are also being explored. [Summary reports from breakout sessions on regulatory agreements, process validation and the question-based review initiative for generics, presented at a recent AAPS/ISPE/FDA-sponsored quality initiative workshop, are included.]
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