FDA Officials Urge Generic Drug Industry to Adopt QbD to Improve Submissions
This article was originally published in The Gold Sheet
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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Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.
Generic drug sponsors will need to submit six-month and 12-month stability data for their ANDAs under draft guidance being developed by the Office of Generic Drugs.