U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Science & Research
  3. Science and Research Special Topics
  4. Clinical Trials and Human Subject Protection
  5. Clinical hold for products intended for life threatening conditions
  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.

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

Back to Top