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.

Generic drug manufacturers will have to place their drugs on stability longer and test more batches under new requirements scheduled to take effect Jan. 1, 2014.

These new requirements will take effect for all abbreviated new drug applications and the drug master files that support them,...

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