The Drug/Biologics Approval Process: An FDLI Primer

January 2013

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by Brian Malkin and Scot Pittman

This publication will explain, in practical terms, the approval processes for drugs and biologics. It will describe the various FDA premarket requirements and pathways for drug and biologics application reviews, including changes enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA). Topics addressed will include the New Drug Application (NDA) process, non-NDA routes to market, generic drugs and the abbreviated new drug application process, as well as over-the-counter drugs and biologics. With this Primer, pharmaceutical stakeholders will feel confident that they have a helpful overview to support successfully navigating the FDA drug and biologics review processes.

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