FDA CDER Small Business and Industry Assistance (SBIA) Chronicles

Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?

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Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? | September 19, 2019 Issue
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FDA CDER Small Business and Industry Assistance (SBIA) ChroniclesBy U.S. Food and Drug Administration, Center for Drug Evaluation and Research