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.

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.

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.