Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Monday October 16, 2000
Over the past two years AIDS Treatment Activists from around the country have advocated within the FDA for a revision of regulatory standards and review for Immune Based Therapies for the treatment of HIV Disease. The Oct. 16 Antiviral Committee Meeting to discuss such practices is viewed as a long awaited step on the part of the FDA.
Activists are inviting Sandy Thurman, the White House Director of AIDS Policy, representatives from Congressman Ed Towns Office and representatives from the National Minority AIDS Council, The National Association of People with AIDS, and other prominent activists, clinicians and advocates.
"We expect the proceedings to be an orderly and productive session that produces constructive dialog with the community, industry and the FDA. We have fought for a long time to ensure this process and are exceedingly happy that the FDA has been able to recognize that these proceedings are essential," said David Miller of the National HIV FDA Regulatory Oversight Committee, an independent organization of AIDS activists who committed to ensuring the progressive development of FDA policies that are reflective of the changing course of the HIV epidemic.
Other AIDS advocates and activists are expressing similar hopes that this is the first major step to be taken by the FDA to administrate necessary reforms that are viewed as impediments to the regulatory advancement and clinical development of immune based therapies.
For more information on this meeting contact Nancy Chamberlin or Beverly O'Neil, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, or by e-mail: CHAMBERLINN@CDER.FDA.GOV. Contact persons can be reached by telephone@ 301-827-7001
For more information contact National HIV FDA Regulatory Oversight Committee, 718-222-4600
SOURCE: National HIV FDA Regulatory Oversite Committee
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