Comment from Association for Accessible Medicines
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Summary: The Association for Accessible Medicines (AAM), representing generic and biosimilar pharmaceutical manufacturers, supports the draft guidance but requests additional clarity on specific technical details. They specifically advocate for clearer guidance on how the FDA determines "carveouts" for generic labeling to ensure NCI exclusivity is not used to unfairly block competition.
AAM comment docket No. FDA-2024-D-4388; New Clinical Investigation Exclusivity (3-Year Exclusivity) DPs: Q&A