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  1. Clinical Trials and Human Subject Protection

Clinical Hold for products intended for life threatening conditions

[Federal Register: June 1, 2000 (Volume 65, Number 106)]
[Rules and Regulations]
[Page 34963-34971]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn00-13]

DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 312 
[Docket No. 97N-0030]

Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions 
AGENCY: Food and Drug Administration, HHS. 
ACTION: Final rule.

SUMMARY: 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.

TEXT: https://www.govinfo.gov/content/pkg/FR-2000-06-01/pdf/00-13664.pdf 

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