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Expert Analysis

Approval Regs Must Change To Keep Up With Biologics Tech

By Eva Temkin and Jessica Greenbaum (September 15, 2023, 4:45 PM EDT) -- The U.S. Food and Drug Administration operates under two different statutory frameworks in its review and approval of drugs: Section 505 of the Federal Food, Drug and Cosmetic Act governs drugs that do not fit within the definition of "biological product," while Section 351 of the Public Health Service Act governs biologics....

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