State Food and Drug Administration

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. 

Introduced in clinical practice in the 1960s, lithium was the first mood stabilizer to be used in China. This was followed by carbamazepine and sodium valproate. For many years, these were the only treatment options available as mood stabilizers. Although lamotrigine was approved for maintenance treatment of bipolar I disorder in 2003 by FDA (Food and Drug Administration) in the USA, this indication has not yet been approved by the Chinese authorities. At present, only one atypical antipsychotic drug, risperidone, has been approved for treating acute mania (February 2005 by SFDA [State Food and Drug Administration]) in China (see Table 6.1). 

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. 

State Food and Drug Administration (SFDA) of China... 

China s State Food and Drug Administration website, http //www.sfda.gov.cn/eng/. 

An application on the prescribed form is submitted to the Department of Drug Registration (DDR) of the State Food and Drug Administration (SFDA). The DDR evaluates the completeness of the document and then forwards it to the Center for Drug Evaluation (CDE) for technical review. External experts may be consulted, and the CDE compiles a technical report for the DDR. 

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