Article | July 29, 2021

ANDA Or 505(B)(2): Choosing The Right Abbreviated Approval Pathway For Your Drug

By Kristi Miller and Rahul Chandrasekhar

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For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug, but the data needed to support an ANDA and 505(b)(2) may differ.

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