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, 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.
Drug Industry Daily