Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal
other · Food and Drug Administration · Rule · Published 2006-05-02 · 71 FR 25747
Document
Document number
06-4091
Federal Register citation
71 FR 25747
CFR reference
21 CFR 210
Type
Rule
Action
Direct final rule; withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-05-02
HHS docket
Docket No. 2005N-0285
Abstract
The Food and Drug Administration (FDA) is withdrawing the direct final rule that published in the Federal Register of January 17, 2006, to amend its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA is withdrawing the rule because significant adverse comments were received.