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FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

This article was originally published in The Tan Sheet

Executive Summary

Commissioner Hamburg says FDA asked for input on a “new paradigm” for nonprescription drug approvals in part because pharmaceutical firms have concerns about whether potential access restrictions imposed on an innovating switch would also apply to generic versions that eventually reach the market.

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FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.

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