1997

FDA Scientists Uncover Factors In The Selective Nature of Sexually-Transmitted HIV: Food and Drug Administration, U.S. Department of Health and Human Services - December 2, 1997; FDA researchers have discovered factors which may make certain strains of HIV-1 more likely to be transmitted through sexual contact than others. These findings, published in the December 1997 issue of Nature Medicine, may have important ramifications for the development of vaccines and post-HIV-1 exposure agents. Th
FDA Scientists Discover Key Mechanism Regulating Immune Cell Actiivity: Food and Drug Administration, U.S. Department of Health and Human Services - December 2, 1997; FDA researchers have discovered a key mechanism by which proteins, called chemokines, direct the traffic of immune cells in response to infections, cancer or other attacks on the body. These findings, published in the December 1 issue of the Journal of Experimental Medicine, have important potential implications for
FDA Warns Consumers About Two Unapproved Home-Use Test Kits: Food and Drug Administration, U.S. Department of Health and Human Services - September 26, 1997; FDA is advising consumers and pharmacists about two unapproved, fraudulently marketed home-use test kits distributed by Lei-Home Access Care, a division of Jin-Greene Biotechnology, Inc. in Sunnyvale, Calif. One test kit is advertised on the internet as the Personal HIV Test Kit and is labeled the Lei-Home Access HI
FDA Proposes to Require Pediatric Data Prior to Drug and Biologic Product Approvals: Food and Drug Administration, U.S. Department of Health and Human Services - August 13, 1997; Ivy Fleischer Kupec: (301) 443-3285; The Food and Drug Administration will require new drugs and biologics to be labeled on how these medicines can be used safely in children. In addition to new drugs, the rule will also apply to many drugs already approved and being used. Currently, most drugs are not labeled for use in children. The proposed rule offers
FDA Issues National Warning on Hommus Dips and Salads Made By Cedar's Mediterranean Foods, Inc.: Food and Drug Administration, U.S. Department of Health and Human Services - June 12, 1997; Bradford Stone: (301) 443-3285; The Food and Drug Administration is issuing a nationwide warning against the purchase and consumption of hommus and other foods produced by Cedar s Mediterranean Foods, Inc., of Plaistow Road, NH. These foods may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infect
FDA Approves First Protease Inhibitors With Labeling For Use In Children: Food and Drug Administration, U.S. Department of Health and Human Services - March 14, 1997; Jason Brodsky: (301) 827-3417; The Food and Drug Administration today approved two HIV protease inhibitors -- some of the most powerful medicines against the infection -- for use in treating children. Nelfinavir received its initial approval today -- including information on use in both adults and children -- approximately 3 months after its applica
Reinventing the Regulation of Human Tissue: Food and Drug Administration, U.S. Department of Health and Human Services - February 28, 1997; Lenore Gelb: (301) 443-3285; The Food and Drug Administration today announced a plan for a new, comprehensive regulatory framework for products derived from cells and tissues that would protect the public health through innovative common-sense government oversight. Today s proposal is the FDA s sixth reinvention reform as part of the Clinton Admin

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©1980, 1997. AEGiS.