American food and drug administration FDA

Currently, tin(II) bis-(2-ethyUiexanoate), also referred as tin octoate, is the most widely used catalyst for the ROP of lactones. This popularity stems from its acceptance by the American Food and Drug Administration (FDA) for the formulation of polymer coatings in contact with food. Moreover, tin(II) bis-(2-ethyUiexanoate) is less sensitivity towards water and other protic impurities than aluminum alkoxides, which facilitates its use in the laboratory and in industry. 

Tin. Tin octoate, Sn(0(0)CCH(C2H5)C4H9)2, abbreviated further as Sn(Oct)2, is one of the more widely used promoter of the ROP of lactones and lactides, owing to its acceptance as a food additive by the American Food and Drug Administration (FDA). Sn(Oct)2 is used at the industrial scale for the... 

The American Food and Drug Administration (FDA 2001) considers the double dose of oral sodium phosphate as an off-label use and warns not to exceed the recommended 45 ml dose. It says that people at increased risk for electrolyte disturbances (e.g. congestive heart failure, renal insufficiency, dehydration) may experience serious adverse effects using oral sodium phosphate. They advise obtaining baseline serum electrolyte values in patients ingesting more than 45 ml of oral sodium phosphate in a 24-h period in order to avoid serious electrolyte problems. 

Tin(II) 2-ethylhexanoate, commonly referred to as stannous octoate (Sn(Oct)2), is the most frequently used catalyst in the ROP and copolymerization of cyclic heterocyclic monomers including cyclic carbonates due to a high activity as well as an approval by the American Food and Drug Administration (FDA) as a food additive. The mechanism of polymerization with its contribution has been widely discussed. Sn(Oct)2 is not thought to be the actual initiator since the molecular weight does not depend on the monomer/Sn(Oct)2 molar ratio. 

Products now marketed in Europe and Asia attain approved status by the U.S. Food and Drug Administration (FDA) and enter the huge and (ucrative American market. 

Alteplase (rt-PA Activase) is an IV thrombolytic (fibrinolytic) that was approved for acute stroke treatment in 1996 based on the results of the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial.10 The current American Stroke Association guidelines include alteplase as the only Food and Drug Administration (FDA) approved acute treatment for ischemic stroke and strongly encourage early diagnosis and treatment of appropriate patients.11... 

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Amphotericin B, a polyene, is discussed more fully in Chapter 52. It has produced healing of the mucocutaneous lesions of American leishmaniasis, but its potential for nephrotoxicity makes it a drug of second choice. On the other hand, liposomal amphotericin B, approved by the U. S. Food and Drug Administration (FDA) for treatment of visceral leishmaniasis, is considered the drug of choice for that indication and is much less toxic than pentavalent antimonials or amphotericin B. 

During the 1990 Washington Conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies [1], parameters that should be used for method validation were defined. The final report of this conference is considered the most comprehensive document on the validation of bioanalytical methods. Many multinational pharmaceutical companies and contract research organizations contributed to its final draft. This scientific meeting was sponsored by the American Association of Pharmaceutical Scientists (AAPS), the Association of Official Analytical Chemists (AOAC), and the U.S. Food and Drug Administration (FDA). The conference report has been used as a reference by bioanalytical laboratories and regulatory agencies worldwide. 

Although ephedrine has been sold for decades, it has recently been reported that this drug is potentially quite dangerous. Ephedrine use has been linked to numerous heart attacks and strokes (see the box on pages 68-69) and was officially banned by the U.S. Food and Drug Administration (FDA) in February 2004. However, prior to its ban, it was estimated that 12 to 17 million Americans were consuming ephedrine-containing products at an estimated 3 billion doses per year. 

After ail exhaustive evaluation of the available Food and Drug Administration (FDA) data on contaminants in American food, three things are certain. 

German chemists knew in the 1900s that barbiturates could be addictive. However, people who took barbiturates did not always exhibit symptoms of drug dependence or withdrawal. By the 1940s, the addictive nature of barbiturates alarmed groups ranging from the American Medical Association (AMA) to the United States Food and Drug Administration (FDA). 

Methylphenidate (e.g., Ritalin and Concerta ) is a stimulant drug prescribed to treat hyperactivity, impulsivity, and inattention in millions of American children. Methylphenidate was first synthesized in the mid-1940s in Europe. In the United States, it was approved by the Food and Drug Administration (FDA) in 1955. The effects of methylphenidate in the human body are almost identical to those of the amphetamines. Amphetamines—the collective name for levoamphetamine (Benzedrine), dextroamphetamine (Dexedrine ), and methamphetamine (Methedrine or speed )—are known to be potent psychomotor stimulants. 

Quality requirements for various clove products is country specific. The American Spice Trade Association (ASTA) and Food and Drug Administration (FDA) recommendations for whole spice (clove) are illustrated in Table 8.10. 

In the USA, there are also no specific decrees or directives for packaging made from recycled materials. However, the Food and Drug Administration (FDA) has published some basic information about the conditions of use of recycled plastics in food packaging applications (US FDA 1992). This information is based on current legislation in the USA and has the backing of American industry (US NFPA 1995). The safety and quality assurance principles involved here concern three fundamental elements ... 

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