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Showing posts with the label drug safety

Drug Approval in the United States

It is important for medical consumers to understand the drug approval process and how to gain access to clinical trials that may cure their illnesses. Drug approval is a complex process but a simple overview and two United States government website can help consumers to understand how drugs are approved. In several developed countries, a uniform procedure exists for determining if new drugs are safe and effective for use in humans. The International Conference on Harmonization created a common format for reporting the results of clinical studies that test new and investigational drugs in patients. The universal document is called the “Common Technical Document” and is accepted in various formats by the European Union, Japan and the United States. The FDA is Responsible for Drug Safety in the United States. In the United States of America, the U.S. Food and Drug Administration, abbreviated FDA , is charged (Code of Federal Regulations 21 CFR 314.50) with maintaining the safety of ...