Investigational New Drug Applications; Clinical Holds; Confirmation of Effective Date
fda-drug · Food and Drug Administration · Rule · Published 1999-04-20 · Effective 1999-04-28 · 64 FR 19269
Document
Document number
99-9768
Federal Register citation
64 FR 19269
CFR reference
21 CFR 312
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
1999-04-20
Effective date
1999-04-28
HHS docket
Docket No. 98N-0979
Abstract
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.