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- Title
Why Does the FDA Place Clinical Holds on Investigational New Drug Clinical Trials?
- Authors
MILLER, DEBORAH J.
- Abstract
The article focuses on a clinical order issued by the U.S. Food and Drug Administration (FDA) for application of investigational new drug (IND) delay in ongoing clinical trial. Topics discussed include safety of clinical trial participants, deficiencies leading to clinical holds such as quality issues and toxicology issues; and protection from there serious and life threatening disease.
- Subjects
CLINICAL trials; PATIENT safety; PHARMACEUTICAL industry; UNITED States. Food &; Drug Administration; HUMAN research subjects; INVESTIGATIONAL drugs
- Publication
ONS Connect, 2016, Vol 31, Issue 12, p24
- ISSN
1935-1623
- Publication type
Article