1996

Vice Presidential Award Presented to FDA's District Office and Merck & Company, Inc.: Food and Drug Administration, U.S. Department of Health and Human Services - October 25, 1996; Stephanie Schwalbe; (301) 443-1130; Two teams -- one from the Food and Drug Administration s District Office in Baltimore, and one from Merck & Co. , Inc. -- will receive on Oct. 28 Vice President Al Gore s Hammer Award for their contribution to the record approval for a significant new treatment for AIDS. The teams close cooperation in field inspec
New Xenotransplantation Guideline Available: Food and Drug Administration, U.S. Department of Health and Human Services - September 20, 1996; Lenore Gelb; (301) 443-3285; The Department of Health and Human Services today proposed a new draft guideline for xenotransplantation -- the transplantation of animal organs and tissue into humans -- aimed at reducing the public health risks while not impeding medical innovation. The recommended procedures announced in the Federal Register today w
FDA Approves First HIV Home Test System: Food and Drug Administration, U.S. Department of Health and Human Services - May 14, 1996; Lenore Gelb; (301) 443-3285; The Food and Drug Administration today approved the first HIV test system that includes collection of blood samples at home. Until now, all HIV tests, whether using blood or saliva samples, were done under the supervision of a health professional at medical facilities, clinics, physicians offices or blood establishment
FDA Approves First Test for HIV Antigen Screening of Blood Donors: Food and Drug Administration, U.S. Department of Health and Human Services - March 14, 1996; Lenore Gelb (301) 443-3285; The Food and Drug Administration today announced the approval of the first antigen test kit to screen blood donors for HIV-1, the virus that is responsible for the vast majority of AIDS cases in the United States . Currently, blood donors are screened with tests that detect HIV antibodies, which typically appear within
FDA Panel Recommends Approval of Third Protease Inhibitor: Food and Drug Administration, U.S. Department of Health and Human Services - March 8, 1996; Ivy Fleischer Kupec; (301) 443-3285; FDA s Antiviral Drugs Advisory Committee met on March 1 and recommended that the agency grant accelerated approval for indinavir alone or in combination with nucleoside analogues for treating HIV infected adults. Indinavir is manufactured by Merck & Co. Inc. under the trade name C
FDA Approves Second Protease Inhibitor to Treat HIV: Food and Drug Administration, U.S. Department of Health and Human Services - March 1, 1996; Ivy F. Kupec; (301) 443-3285; The Food and Drug Administration today approved the second in a new class of AIDS drugs called protease inhibitors . Ritonavir , the new drug, received full approval for use alone or in combination with nucleoside analogue medications, such as
FDA Advisory Committee to Discuss Various AIDS Treatments: Food and Drug Administration, U.S. Department of Health and Human Services - February 2, 1996; Ivy Fleischer Kupec; (301) 443-3285; The Food and Drug Administration will convene a Feb. 28- March 1 meeting of its Antiviral Drugs Advisory Committee and other outside experts to review marketing applications for two protease inhibitor drugs to treat HIV infection and to discuss recent studies of the clinical effectiveness of nucleoside analogue drugs u

This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1980, 1996. AEGiS.