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2010-09-23
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Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions
Rules and Regulations
D09002ee1bdfaa188
D09002ee1bdfaa233
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
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.
65 FR 34963
https://www.govinfo.gov/app/details/FR-2000-06-01/00-13664
00-13664
fr01jn00-13
4160-01-F
Docket No. 97N-0030
https://www.govinfo.gov/app/details/FR-2000-06-01/00-13664
https://www.govinfo.gov/content/pkg/FR-2000-06-01/html/00-13664.htm
https://www.govinfo.gov/content/pkg/FR-2000-06-01/pdf/00-13664.pdf
Drugs
Exports
Imports
Investigations
Labeling
Medical Research
Reporting and Recordkeeping Requirements
Safety
9 p.
34963
34971
65 FR 34963
Code of Federal Regulations
Title 21 Part 312
21 CFR Part 312
Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions; Federal Register Vol. 65, Issue
RULE
00-13664
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2000-07-31
Docket No. 97N-0030
4160-01-F
00-13664
Final rule.
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.
The regulation is effective July 31, 2000.
Andrea C. Masciale, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
Drugs
Exports
Imports
Investigations
Labeling
Medical Research
Reporting and Recordkeeping Requirements
Safety
Human drugs:
Investigational new drugs and new drug applications
Products intended for life-threatening diseases and conditions; clinical hold regulations,
Federal Register
Vol. 65, no. 106
Office of the Federal Register, National Archives and Records Administration
2000-06-01
continuing
daily
deposited
born digital
355 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2000-06-01
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https://www.govinfo.gov/app/details/FR-2000-06-01
https://www.govinfo.gov/content/pkg/FR-2000-06-01/pdf/FR-2000-06-01.pdf
https://www.govinfo.gov/content/pkg/FR-2000-06-01/xml/FR-2000-06-01.xml
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2010-09-23
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FR-2000-06-01
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FR-2000-06-01
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