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For investigators and sponsors operating in the U.S., section 113 of the Food and Drug Modernization Act of 1997 (FDAMA) mandates the registration of clinical trials that evaluate the efficacy of drugs for serious or life-threatening diseases and conducted under an Investigational New Drug application.
See the following for additional information:
FDA Guidance Document on FDAMA 113
FDA Information Page on FDAMA 113
Draft FDA Guidance Document covering the Best Pharmaceuticals for Children Act
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