FDA Officials Urge Generic Drug Industry to Adopt QbD to Improve Submissions
First to file, worst to file? FDA looks to turn the tables on the generics submissions race and award first-to-file status to ANDA applicants who invest in quality by design. Agency urges generics firms to adopt QbD approach by 2011. The problem is many non-QbD first-to-file ANDAs languish in review while firms learn how to make the products, wasting industry and FDA resources - especially with complex modified-release products. Once in production, recalls and warning letters could follow while firms continue learning the hard way.
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