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- Title
INDEPENDENT DRUG TESTING TO ENSURE DRUG SAFETY AND EFFICACY.
- Authors
RODWIN, MARC A.
- Abstract
The article offers information on the significant implementation of the independent drug testing to ensure efficacy and safety in design and conduct of clinical trials for new drug applications (NDA) under the provisions of the Federal Food, Drug, and Cosmetic Act. Topics discussed include the drug approval by the Food and Drug Administration (FDA), the significance of the Contract Research Organizations (CRO) in clinical trials, and the American Medical Association in federal drug regulations.
- Subjects
UNITED States; DRUG use testing laws; CLINICAL trial laws; DRUG approval; DRUG design; UNITED States. Federal Food, Drug, &; Cosmetic Act; UNITED States. Food &; Drug Administration; CONTRACT research organizations; AMERICAN Medical Association
- Publication
Journal of Health Care Law & Policy, 2015, Vol 18, Issue 1, p45
- ISSN
1097-4768
- Publication type
Article