Food and Drag Administration

Examples of the new generation of NNRTIs are etravirine (TMC125) and rilpivirine (TMC278), with activity against both wild type and resistant viral isolates. Etravirine was approved by the US Food and Drag Administration in lanuary 2008 and is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other ARV agents. 

In the United States, the threshold mercury concentration for commercial sale of fish is determined by the Food and Drag Administration, whereas consumption advice for recreational (noncommercial) fish is developed by individual states and tribes. Mercury data collected for development of fish-consumption advisories are typically from analyses of filets (axial muscle tissue, with or without skin) for total mercury, with concentrations expressed on a wet-weight basis. Analysis of filets for total mercury yields a valid estimate of MeHg concentration (Grieb et al. 1990 Bloom 1992), whether the analyzed sample consists of a large filet or a small mass of tissue obtained with a biopsy needle (Cizdziel et al. 2002 Baker et al. 2004). 

Emperor s New Drugs An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drag Administration , Prevention Treatment, no. 23 (2002a) http //www.joumals.apa.org/preven-tion/volume5/pre0050023a.html... 

GM-CSF was approved in 1991 by the United States Food and Drag Administration (FDA) to support transplant associated neutropenia and mobilize stem cells. In Europe, it is also approved for prophylactic treatment following dose intensive chemotherapy. However, the rate of absolute neutrophil count (ANC) recovery in response to treatment with GM-CSF in patients receiving myelosuppressive chemotherapy or in the... 

The Food and Drag Administration Modernization Act to streamline the drug and device review and approval process. 

From 1978 through 1990, the Centers for Disease Control and Prevention (CDC) and the Food and Drag Administration divided the responsibility for postmarketing surveillance of vaccines in the United States. FDA received reports of adverse events after vaccines were administered in the private sector events occurring after the administration of vaccines purchased with public funds were reported to the Monitoring System for Adverse Events Following Immunization. 

Copies of regulations governing the listing, certification, and use of colors in foods, drags, devices, and cosmetics shipped in interstate commerce or offered for entry into the United States, or answers to questions concerning them, are available from the Food and Drag Administration. Recommendations on submission of chemical and technological data are provided in the FDA s online publication (http //vm.cfsan.fda.gov/ -dms/opa-coll.html). 

Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, Washington, US Food and Drag Administration, 1982 and draft revision 1993. 

Petitions for the use of a new food additive may be submitted to the Food and Drag Administration in accordance with the form specified in the regulations. 

Figure 8.5 NDA/BLA drag median approval times. (Source Food and Drag Administration. FY 2006 Performance Report to the President and the Congress, FDA, Rockville, MD, 2006. http //www.fda.gOv/ope/pdufa/report2006/PDUFA2006perf.pdf [accessed September 20, 2007].)...

Raman spectroscopy was discovered over 75 years ago but has only been a viable process tool for 10-15 years. However, there has been an astounding increase in process Raman spectroscopy examples in the last five years. The United States Food and Drag Administration s (US FDA) endorsement of process analytical technology clearly set off an explosion of activity. Problems that sometimes sidelined Raman in the past, such as fluorescence or highly variable quantitative predictions from samples that were too small to be representative, are being re-examined and leading to new technology. In turn, that helps open, or perhaps reopen, new application areas. The availabihty of easy to use Raman instrumentation at many prices also helps with that. 

No. 16), Geneva, International Programme on Chemical Safety, pp. 70-73 Food and Drag Administration (1999) Food and drags. US Code Eed. Regul., Title 21, Part 189, SnbpartB, Section 189.113, p. 549... 

Food and Drag Administration hltp Z/wvvw fda.gnvZ... 

FDA compliance program guidance manual. National drug residue milk monitoring program. Food and drag administration. Rockville, MD, section 7303.039,1997. 

Food and Drag Administration website, . July 5, 2002 (July 8, 2002). 

Center for Drug Evaluation and Research. U.S. Food and Drag Administration. 18 July 2002. [Pg.253]

Food and Drag Administration. The Story of the Laws Behind the Labels Part I. The 1906 Food and Drugs Act. FDA Consumer (June 1981). . 

Department of Health and Human Services, Food and Drag Administration, 21 CFR Part 11, Electronic Records Electronic Signatures, Federation Register 62 (54), 13430-13466, March 20, 1997. 

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