Viral Load in Clinical Trials: FDA Advisory Committee Meeting July 14-15

An important public meeting on using sustained changes inviral load as a substitute for clinical endpoints in certain trials of antiretroviral drugs will be held July 14 and 15 near Washington, D.C. The FDA's Antiviral Drugs Advisory Committee will meet from 8:30 a.m. to 5:00 p.m. each day in Room 204 of the Armory Place, 925 Wayne Avenue, Silver Spring, Maryland. (On July 16 the Advisory Committee will also meet at the same time and place, but on a separate topic-- approval of AmBisome(R) liposomal amphotericin B as empirical therapy for presumed fungal infection in febrile, neutropenic patients.) All three days of meetings are open to the public.

Persons who want "to participate in the open public hearing or to submit data, information or views to the committee" may do so during a public hearing scheduled for July 14 from 11a.m. to noon. Those who want to speak should notify Rhonda Stover or John Schupp, at the Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 301/443-5455, or by fax at 301/443-0699, by July 7.

The Armory Place is near the Silver Spring Metro stop. Long-term metered parking is available at Fenton Street and Pershing Drive (payable with quarters only), and there is other parking in the area.

If there are any changes to the meeting schedule, they will be announced on the FDA Advisory Committee Hotline, 800/741-8138 or 301/443-0572. The 5-digit code number for information about the Antiviral Drugs Advisory Committee is 12531.