Investigational New Drug Applications; Clinical Holds; Confirmation of Effective Date

Resumo

The Food and Drug Administration (FDA) published in the Federal Register of December 14, 1998 (63 FR 68676), a direct final rule. The direct final rule amends FDA's regulations governing investigational new drug applications (IND's) for human drug and biological products. This action amends the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. This document confirms the effective date of the direct final rule.