list of approved ndas for biological products

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  1. madman

    The FDA and hCG: Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020

    On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the...
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