Food and Drug Administration , United States

The opinions expressed in this chapter are solely those of the authors and do not necessarily reflect those of the United States Food and Drug Administration. 

This section will review the phase III clinical trials of IV thrombolytic agents for acute ischemic stroke, organized by the type of agent and the time window from stroke onset to study drug delivery (Table 3.1). The 1995 National Institute of Neurological Disorders and Stroke (NINDS) rt-PA trial is presented first because it showed that IV rt-PA, given within 3 hours of stroke onset, reduced stroke-related disability. This trial was the basis for the United States Food and Drug Administration (FDA) approval for rt-PA for use in acute ischemic stroke. 

USFDA, The United States Food and Drug Administration details its standard methods in the Code of Federal Regulations, Title 21. 

AO AC Technical Division on RMs United States Department of Defense United States Food and Drug Administration US Geological Survey United States Pharmacopoeia Valid Analytical Measurement, UK World Health Organization... 

Table 10 lists United States Food and Drug Administration (FDA) submissions in 2000 for commercial GMOs, including the food, gene, source and intended... 

United States Food and Drug Administration, Washington, DC, http //www.cfsan.fda.gov/ lrd/biocon.html. 

Fluoroquinolones Not approved by the United States Food and Drug Administration for use in children except for anthrax (ciprofloxacin). MRSA, methicillin-resistant 5. aureus MSSA, methicillin-sensitive 5. aureus. 

United States Food and Drug Administration.(1992). FDA s policy statement for the development of new stereoisomeric drugs. Chirality 4, 338-340. 

EC = European Comission US FDA — United State Food and Drug Administration for EC data not available. 

FDA, Guidance for Industry Drugs, Biologies, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Draft Guidance). United States Food and Drug Administration,... 

United States Food and Drug Administration Pharmaceutical Research and... 

FDA. 1998a. Everything added to food in the United States. Food and Drug Administration. http //vm.cfsan.fda.gov/ dms/eafus.html. Accessed on Nov. 22, 1998. 

There are many conspicuous examples of different actions by enantiomeric isomers of the molecules of various drugs. Suffice it to mention thalidomide, which was known as Contergan in Europe and with which many tragedies were connected before it was withdrawn from the market. Since 1992, the United States Food and Drug Administration and the European Committee for Proprietary Medicinal Products have required manufacturers to research and characterize each enantiomorph of a potential drug. ... 

Cohen, M. H., Williams, G. A., Sridhara, R., et al. (2004) United States Food and Drug Administration drug approval summary gefitinib (ZD1839 Iressa) tablets. Clin Cancer Res. 10, 1212-1218. 

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