# Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal
> **Food and Drug Administration** · Direct final rule; withdrawal. · Published 2006-05-02 · 71 FR 25747
## Document
- **Document number:** 06-4091
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 71 FR 25747
- **CFR reference:** 21 CFR 210
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2006/05/02/06-4091/current-good-manufacturing-practice-regulation-and-investigational-new-drugs-withdrawal)
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