FDA advisory hearing on new-fill (Sculptra), March 25, 2004 in Gaithersburg, Maryland.On March 25, 2004 the FDA's General and Plastic Surgery Devices Panel will hold a public hearing on "a premarket approval application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. (human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. ) positive patients." AIDS Treatment News has learned that the application is for Sculptra, which is marketed in Europe under the name New-Fill. According to the Web site Drugs.com, it has been used by an estimated 100,000 people worldwide for various facial treatments. Those who want to speak at the hearing should notify the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. before March 15. For more information on the logistics, visit: http://www.fda.gov/cdrh/panel/index.html Click on "Upcoming CDRH Advisory Committee/Panel Meetings" then on "Details" for the March 25, 2004 meeting. Also, background information on this application will be available to the public one day before the meeting, at: http://www.fda.gov/cdrh/panelmtg.html |
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