# Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions
> **Food and Drug Administration** · Final rule. · Published 2000-06-01 · Effective 2000-07-31 · 65 FR 34963
## Document
- **Document number:** 00-13664
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 34963
- **CFR reference:** 21 CFR 312
- **Publication date:** 2000-06-01
- **Effective date:** 2000-07-31
- **HHS docket:** Docket No. 97N-0030
## Abstract

The Food and Drug Administration (FDA) is amending the regulations governing investigational new drug applications (IND's) to permit FDA to place a clinical hold on one or more studies under an IND involving a drug that is intended to treat a life-threatening disease or condition affecting both genders. The amendments permit the agency to place a clinical hold on such studies if men or women with reproductive potential who have the disease or condition are otherwise eligible but are categorically excluded from participation solely because of a perceived risk or potential risk of reproductive or developmental toxicity from use of the investigational drug. This rule was developed in response to the past practice of excluding women with reproductive potential from early clinical trials because of a perceived risk or potential risk of reproductive or developmental toxicity. The final rule does not impose requirements to enroll or recruit a specific number of men or women with reproductive potential.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/06/01/00-13664/investigational-new-drug-applications-amendment-to-clinical-hold-regulations-for-products-intended)
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