Generics Firms Raise Concerns About FDA’s Stability Testing Guidance
This article was originally published in The Gold Sheet
Executive Summary
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.