Federal Drugs Administration

The Federal Drug Administration (FDA) describes the biopharmaceutical industries as self-regulated, retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprisingly, then. 

Subsequently the medication was approved for self identified African Americans by the Federal Drug Administration (FDA), the first time a medication was approved for a specific racial group (US Food and Drug Administration, 2005). This combination was then marketed as BiDil. The approval led to a great deal of controversy and discussion, much of it critical, about the FDA decision. The findings from these trials, however, provide evidence that ethnicity can make a difference in clinical treatment response (Sankar 8c Kahn, 2005). 

For these proteins, mammalian cells proved better hosts, as they could process the protein with intracellular machinery similar to that in humans. However, large-scale production of proteins in cell culture was problematic. Mammalian cells had to grow attached to a solid surface, such as glass in roller bottle culture. While the Federal Drug Administration (FDA) had approved some processes for vaccine production that used cell cultures, it required that these cells be normal. Normal mammalian cells can divide only a few times before they stop growing, making scale-up to large volumes difficult. 

Detailed pharmacokinetic investigations are a necessary prelude to the formal approval protocols of the Federal Drug Administration and its counterparts worldwide. Although this topic lies beyond the scope of this Hand-... 

Methylphenidate also has been combined with clon-idine, the a.2 agonist, to reduce aggression, to provide better control of ADHD symptoms after the stimulant wears off, and to counteract insomnia associated with stimulant treatment (Wilens et ah, 1994). The report of four deaths on the Federal Drug Administration (FDA) s MEDWATCH surveillance network, however,... 

In 1972 the Federal Drug Administration (FDA) initiated an OTC drug study. The final report of seventeen advisory panels was issued in 1983. Only one-third of the 700 active ingredients in some 300.000 OTC products were found to be effective. Then in November 1990 the FDA banned 223 drugs found in OTCs because their therapeutic claims were unsubstantiated. All of the products affected had been in use since before 1962. 

VI. COMMENTARY ON FEDERAL DRUG ADMINISTRATION GUIDANCE ON THE USE OF IN VITRO MODELS TO DETERMINE P-gp-RELATED IN VIVO DDI POTENTIAL OF DISCOVERY/DEVELOPMENT CANDIDATES... 

UK,DEPT.OF HEALTH UK,NATIONAL HEALTH SERVICE EU,SCIENTIFIC COMMITTEE ON MEDICINAL PRODUCTS MEDICAL DEVICES HEALTH CANADA US,FEDERAL DRUGS ADMINISTRATION... 

U.S. Army Medical Command. (1999). Medical management of chemical casualties course, medical response to chemical warfare and terrorism [Satellite broadcast]. Aberdeen Proving Ground, MD U.S. Army Medical Research Institute for Chemical Defense and U.S. Federal Drug Administration. 

In 1991 Bristol-Myers Squibb in conjunction with the NCI agreed to manage the supplies of paclitaxel and were granted a licence to further develop the compound. The following year the US. Federal Drug Administration approved paclitaxel for the treatment of ovarian cancer in patients unresponsive to standard treatments, and in December 1993 approval was given for the treatment of metastatic breast cancer. 

In Canada, the use of antioxidants is regulated under the Food and Drug Act (Heath Canada), and in United States, it is regulated by the Federal Drug Administration and the U.S. Department of Agriculture. When it comes to the European Economic Community, directives regulate the use of antioxidants however, individual member countries stiU have the control of usage levels. In Japan, the Food Sanitation Law specifies the use of antioxidants (48). 

FDA—The Unites States Federal Drug Administration oversees and regulates the introduction of new drug products into the medical marketplace. 

L-glutamic acid and its ammonium, calcium, monosodium, and potassium salts were evaluated by the Joint FAOAVHO Expert Committee on Food Additives (JECFA) in 1988 (6). Because human studies had failed to confirm involvement of monosodium glutamate in the Chinese restaurant sjmdrome or other reactions, the JECFA classified glutamic acid and its salts under the heading acceptable daily intake (ADI) not specified. The Scientific Committee for Food (SCF) of the European Commission reached a similar conclusion in 1991, and the conclusions of a subsequent review by the Federation of American Societies for Experimental Biology (FASEB) and the Federal Drug Administration (FDA) did not discount the existence of a sensitive subpopulation but otherwise concurred with the evaluations of JECFA and the SCF. 

The Church of Scientology attempted to convince the Federal Drug Administration (FDA) to pull Prozac from the market. However, the FDA ruled against taking such action because there was no scientific evidence to support the claims made by the Church of Scientology (Burton 1991). 

Federal Drug Administration. (2002). FDA approves Xyrem for cataplexy attacks in patients with narcolepsy. FDA Talk Paper, July 17. 

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