other · Food and Drug Administration · Rule · Published 1997-09-05 · Effective 1997-11-04 · 62 FR 46875
Document
Document number
97-23587
Federal Register citation
62 FR 46875
CFR reference
21 CFR 312
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-09-05
Effective date
1997-11-04
HHS docket
Docket No. 95N-0138
Abstract
The Food and Drug Administration (FDA) is amending the investigational new drug regulation that provides for disqualification of clinical investigators who submit false information. The revision is intended to clarify the agency's authority to reach sponsor- investigators under the regulation.