AEGiS-ATN: FDA Advisory Hearing on New-Fill (Sculptra), March 25, 2004 in Gaithersburg, Maryland

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

FDA Advisory Hearing on New-Fill (Sculptra), March 25, 2004 in Gaithersburg, Maryland

AIDS TREATMENT NEWS "alert" February 18, 2004
John S. James

On March 25, 2004 the FDA's General and Plastic Surgery Devices Panel will hold a public hearing on "a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) 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.

The meeting will be held at the Hilton Washington, DC North, in Gaithersburg, Maryland. Those who want to speak should notify the FDA by 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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