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
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, issued by the agency in August, 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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