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Generics Joining the 12-Month Stability Data Club, But 'When?' Is Big Question

This article was originally published in The Gold Sheet

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Generics Firms Raise Concerns About FDA’s Stability Testing Guidance

The generic drug industry needs to place more drug batches on stability for a longer time to meet the new, stricter stability testing requirements scheduled to take effect Jan. 1, 2014. However, industry says there are still some outstanding issues that need to be resolved before these new requirements go into effect, such as the size of pilot batches subject to testing.

Failed ANDA Bioequivalence Studies Haven’t Impacted Review Decisions, FDA Says

Bioequivalent studies that fail to show bioequivalence between a generic drug and its reference product have not been a factor in ANDA approvals, Barbara Davit, acting director of the Office of Generic Drugs’ Division of Bioequivalence 2, reported at the Generic Pharmaceuticals Association’s fall technical meeting on Oct. 5 in Bethesda, Md.

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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