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BioPharmaceutical United States Regulation

ANDA Lull Begins: OGD Receives Four Applications In July

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Executive Summary

A former FDA official suggests ANDA sponsors are waiting until the Office of Generic Drugs launches its formal review goals in October before filing applications.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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