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Home » GPhA Calls FDA’s Fourth ANDA Stability Test Time Point an Overreach

GPhA Calls FDA’s Fourth ANDA Stability Test Time Point an Overreach

October 31, 2013
GPhA wants the FDA to eliminate a proposed requirement that ANDA sponsors submit an additional, fourth stability time point for accelerated testing conditions, which the group says is not consistent with international regulations. Responding to a draft question-and-answer guidance on the testing issue, the group said no other highly regulated region in the world requires a fourth stability time point, and that the requirement never came up during stakeholder meetings with the agency.
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