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Abstract: Freewheeling and emotional testimony was the order of the day during a Food and Drug Administration hearing on the Early Availability of Drugs for Serious or Life-Threatening Diseases. The September 12 to 13 event, held under the auspices of the FDA s Antiviral Drugs Advisory Committee provided a stage for a wide range ...
http://www.aegis.org/pubs/gmhc/1994/gm080907.html
File Name: gm080907.html, Size: 9KB, Last Modified: Thursday, May 21, 2009 at 9:28:14 PM
Abstract: Note: The following statement was developed by many people, collectively calling themselves the Protease Consensus Coalition. It has been signed by 61 organizations, including ACT UP/New York Treatment and Data Committee, AIDS Project Los Angeles, AIDS Research Alliance (formerly Search Alliance), AIDS Treatment News, ...
http://www.aegis.org/pubs/atn/1995/atn21903.html
File Name: atn21903.html, Size: 11KB, Last Modified: Monday, January 12, 2009 at 9:57:56 PM
Abstract: [The U.S. Food and Drug Administration has requested public comment for the September 12-13 meeting of its Antiviral Advisory Committee, which will examine accelerated approval -- the regulations now in effect which allow critically needed drugs to be approved based on blood tests which show virological or immunologica ...
http://www.aegis.org/pubs/atn/1994/atn20603.html
File Name: atn20603.html, Size: 11KB, Last Modified: Monday, January 12, 2009 at 9:57:47 PM
Abstract: A two-day public meeting of the FDA Antiviral Advisory Committee is shaping up as one of the important AIDS policy and community meetings of the year. It is important to let the FDA and the pharmaceutical industry know that the AIDS community insists on early access to new treatments, and strongly supports accelerated ...
http://www.aegis.org/pubs/atn/1994/atn20504.html
File Name: atn20504.html, Size: 11KB, Last Modified: Monday, January 12, 2009 at 9:57:46 PM
Abstract: The Antiviral Drug Products Advisory Committee, a panel of outside experts convened by the U.S. Food and Drug Administration, will hold a public hearing on whether d4T (generic name stavudine , brand name ...
http://www.aegis.org/pubs/atn/1994/atn19804.html
File Name: atn19804.html, Size: 8KB, Last Modified: Monday, January 12, 2009 at 9:57:41 PM
Abstract: The U. S. Food and Drug Administration has formalized and published in the Federal Register a proposal for accelerated approval of drugs for serious or life-threatening illnesses. Written comments can be submitted through June 15. These comments will be considered in drafting the final rule. The published document comb ...
http://www.aegis.org/pubs/atn/1992/atn15106.html
File Name: atn15106.html, Size: 9KB, Last Modified: Monday, January 12, 2009 at 9:57:11 PM
Abstract: AEGIS, AIDS Daily Summary, HIV, AIDS, HIV infection, opportunistic infections. var gaJsHost = (https: = document.location.protocol) ? "https:ssl. : "http:www. document.write(unescape(3Cscript src= + gaJsHost + "google-analytics.com/ga.js' type=text/javascript'3E%3C/script%3E"ion" CONTENT=The FDA has ...
http://www.aegis.org/news/ads/1994/ad941579.html
File Name: ad941579.html, Size: 10KB, Last Modified: Sunday, January 04, 2009 at 6:48:35 PM
Abstract: AEGIS, AIDS Daily Summary, HIV, AIDS, HIV infection, opportunistic infections. var gaJsHost = (https: = document.location.protocol) ? "https:ssl. : "http:www. document.write(unescape(3Cscript src= + gaJsHost + "google-analytics.com/ga.js' type=text/javascript'3E%3C/script%3E"ion" CONTENT=Only a few y ...
http://www.aegis.org/news/ads/1994/ad941561.html
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Abstract: The Food and Drug Administration ( FDA ), on January 18, 2007, granted accelerated approval for etravirine 100 mg tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI), an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV virus replication. It is the first NNRTI to demons ...
http://www.aegis.org/news/fda/2008/fd080102.html
File Name: fd080102.html, Size: 11KB, Last Modified: Thursday, November 06, 2008 at 5:24:01 PM
Abstract: WASHINGTON, Jan. 30 /PRNewswire/ -- The AIDS Institute, a national public policy research, advocacy, and education organization, is encouraged with the FDA s approval of the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in nearly a decade. TMC125/etravirine was developed by Tibotec Pharmaceuticals, L ...
http://www.aegis.org/news/pr/2008/pr080147.html
File Name: pr080147.html, Size: 9KB, Last Modified: Wednesday, January 30, 2008 at 3:00:00 PM
Abstract: With the Food and Drug Administration s handling of drug safety already under a microscope, the suspension of multiple-sclerosis drug Tysabri creates a new area for scrutiny: the agency s process for rushing out promising new treatments for the most serious conditions. Biogen Idec Inc. and Elan Corp. yesterday announce ...
http://www.aegis.org/news/wsj/2005/wj050301.html
File Name: wj050301.html, Size: 13KB, Last Modified: Tuesday, March 06, 2007 at 7:28:36 PM
Abstract: The Food and Drug Administration today, June 23, 2006, granted accelerated approval for Prezista (darunavir - formerly known as TMC-114), a new drug for treatment experienced adults whose infection with the human immunodeficiency virus (HIV) is not responding to treatment with other antiretroviral drugs. Prezista, a pr ...
http://www.aegis.org/news/fda/2006/fd060603.html
File Name: fd060603.html, Size: 9KB, Last Modified: Tuesday, March 06, 2007 at 5:40:28 PM
Abstract: The Food and Drug Administration ( FDA ) today announced the accelerated approval of Fuzeon (enfuvirtide) for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older. The accelerated approval of this new drug should provide new hope for those su ...
http://www.aegis.org/news/fda/2003/fd030302.html
File Name: fd030302.html, Size: 10KB, Last Modified: Tuesday, March 06, 2007 at 5:40:18 PM
Abstract: 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 ...
http://www.aegis.org/news/fda/1996/fd960302.html
File Name: fd960302.html, Size: 9KB, Last Modified: Tuesday, March 06, 2007 at 5:40:15 PM
Abstract: The Food and Drug Administration today announced its accelerated approval for the drug lamivudine, or 3TC , for use in combination with AZT (zidovudine) in treating AIDS and HIV infection. AZT and 3TC are members of the nucleoside analogue class of drug compounds ...
http://www.aegis.org/news/fda/1995/fd951101.html
File Name: fd951101.html, Size: 9KB, Last Modified: Tuesday, March 06, 2007 at 5:40:14 PM
Abstract: The FDA gave accelerated approval to a new anti-HIV drug called APTIVUS, which when used with other drugs was twice as effective as other drug combinations. A powerful new anti-HIV drug was unveiled Thursday to help patients in whom the virus has overcome other drugs and begun to replicate again. APTIVUS, when used ...
http://www.aegis.org/news/mh/2005/mh050610.html
File Name: mh050610.html, Size: 9KB, Last Modified: Friday, June 24, 2005 at 3:00:00 PM
Abstract: WASHINGTON - The government s fast-track system for making new medications quickly available to treat the deadliest illnesses has become a route for companies to market drugs without fully proving their effectiveness or safety - either before or after they go on the market, according to a congressional report to be rel ...
http://www.aegis.org/news/lt/2005/lt050602.html
File Name: lt050602.html, Size: 11KB, Last Modified: Wednesday, June 01, 2005 at 3:00:00 PM
Abstract: Accelerated drug approval was one of most important accomplishments of early AIDS activism. In a sense, it was the "final draft" of several earlier proposals, all of which pursued the same goal: getting new drugs to people in need more quickly. Accelerated approval differed from earlier, similar proposals in that it re ...
http://www.aegis.org/pubs/rita/2002/ri020705.html
File Name: ri020705.html, Size: 24KB, Last Modified: Monday, February 02, 2004 at 11:20:34 PM
Abstract: GAITHERSBURG, Md. (AP-Dow Jones)--Medical and statistical reviewers for the Food and Drug Administration say Pharmacia & Upjohn Inc. s (PNU) proposed AIDS drug delavirdine has some anti-HIV activity, but officials added the data were not robust. Agency reviewers said one study showed no clinical benefit, but late ...
http://www.aegis.org/news/ap/1996/ap961112.html
File Name: ap961112.html, Size: 10KB, Last Modified: Saturday, November 23, 1996 at 3:00:00 PM
Abstract: Hoffmann-La Roche received accelerated approval from the Food and Drug Administration ( FDA ) for its protease inhibitor, saquinavir ( Invirase ), when used in combination with nucleoside analogues. This is the ...
http://www.aegis.org/aidsline/1996/sep/m9690289.html
File Name: m9690289.html, Size: 9KB, Last Modified: Saturday, September 28, 1996 at 8:12:04 PM
Abstract: WASHINGTON, March 14 /PRNewswire/ -- The Food and Drug Administration announced today it has granted accelerated approval to the third in a new class of AIDS drugs called protease inhibitors . Indinavir , the new drug, received accelerated approval late yesterday for use alone or in combination with nucl ...
http://www.aegis.org/news/pr/1996/pr960316.html
File Name: pr960316.html, Size: 10KB, Last Modified: Thursday, March 14, 1996 at 3:00:00 PM
Abstract: Accelerated approval of new anti-HIV compounds is a necessary component of drug development in order to make new compounds quickly available to populations that often have exhausted all other treatment options. However, one undesirable results of the current accelerated approval system for new antiretrovirals is that ...
http://www.aegis.org/aidsline/1995/dec/m95c2830.html
File Name: m95c2830.html, Size: 10KB, Last Modified: Thursday, December 28, 1995 at 8:12:04 PM
Abstract: The antivirals d4T and ddC have been given accelerated approval status, providing more treatment options for persons who cannot tolerate or have developed resistance to ...
http://www.aegis.org/aidsline/1995/nov/m95b0895.html
File Name: m95b0895.html, Size: 9KB, Last Modified: Tuesday, November 28, 1995 at 8:12:04 PM
Abstract: The Protease Consensus Coalition has developed the Consensus Statement on the Accelerated Approval of Protease Inhibitors. The statement has been signed by 61 organizations, as well as over 100 individuals. According to the statement, access to protease inhibitor drugs now in development represents the best hope for d ...
http://www.aegis.org/aidsline/1995/nov/m95b0907.html
File Name: m95b0907.html, Size: 9KB, Last Modified: Tuesday, November 28, 1995 at 8:12:04 PM
Abstract: WASHINGTON, Nov. 20 /PRNewswire/ -- The Food and Drug Administration today announced its accelerated approval for the drug lamivudine, or 3TC , for use in combination with AZT (zidovudine) in treating AIDS and HIV infection. AZT and 3TC are members of the nucleoside analogue class of drug c ...
http://www.aegis.org/news/pr/1995/pr951134.html
File Name: pr951134.html, Size: 10KB, Last Modified: Monday, November 20, 1995 at 3:00:00 PM
Abstract: FDA spokesman Arthur White said recently that the agency would not change its policy on accelerated approval for medications for life-threatening conditions. The agency remains fully committed to fast-track approval, said Whitmore. The FDA held a public meeting in September, at which researchers and manufacturers exp ...
http://www.aegis.org/news/ads/1995/ad950110.html
File Name: ad950110.html, Size: 9KB, Last Modified: Wednesday, January 18, 1995 at 3:00:00 PM
Abstract: WASHINGTON -- The Food and Drug Administration Monday reopened the contentious debate over the speedy approval of new AIDS drugs in response to a growing split within the usually unified network of AIDS patients and their advocates. The activist community continues to support a 1992 decision by the agency to license th ...
http://www.aegis.org/news/lt/1994/lt940903.html
File Name: lt940903.html, Size: 9KB, Last Modified: Tuesday, September 13, 1994 at 3:00:00 PM
Abstract: d4T (Stavudine) approved by FDA. U.S. Department of Health and Human Services, Food and Drug Administration - p94-13; June 27, 1994 Arthur Whitmore (301) 443-3285The Food and Drug Administration today announced the approval of stavudine, or. the fourth drug approved for the treatment of AIDS and HIV infection.. ...
http://www.aegis.org/pubs/cdc_fact_sheets/1994/cdc94036.html
File Name: cdc94036.html, Size: 6KB, Last Modified: Wednesday, July 27, 1994 at 11:00:00 PM
Abstract: ddC Approved and Withdrawn In a two-day meeting full of ironic twists, the FDA Antiviral Advisory Committee voted on September 20 to fully approve ddC monotherapy and withdraw combination AZT /ddC s accelerated approval. ...
http://www.aegis.org/pubs/gmhc/1993/gm070902.html
File Name: gm070902.html, Size: 10KB, Last Modified: Thursday, May 21, 2009 at 9:28:12 PM
Abstract: The news did not make it to the front pages, but on Feb. 28 a powerful member of the U.S. Senate launched an attack on the Food and Drug Administration, the drug companies and the desperate cancer patients they treat. Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee, requested that the Govern ...
http://www.aegis.org/news/wsj/2008/wj080504.html
File Name: wj080504.html, Size: 13KB, Last Modified: Thursday, May 29, 2008 at 3:00:00 PM