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Business · 14/12/1998

FDA Proposes Changes to Investigational New Drug Applications Clinical Holds

The Food and Drug Administration (FDA) is proposing to update its regulations for investigational new drug applications (INDs) for human drugs and biological products, aiming to streamline the process of removing clinical holds from investigations within 30 days of a sponsor's request and response.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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