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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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This article discusses processes for the successful promotion of an accelerated approval product under FDA’s 1992 Accelerated Approval Program for drugs under 21 CFR Part 314 Subpart H and for biologics under 21 CFR Part 601 Subpart E.
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