Anti-Infective Drugs Advisory Committee; Notice of Meeting

Zusammenfassung

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on April 26, 2001, 8 a.m. to 6 p.m., and on April 27, 2001, 8:30 a.m. to 12 noon. Location: Holiday Inn, The Ballrooms, 8120 Wisconsin Ave., Bethesda, MD. Contact: Thomas H. Perez, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6758, e-mail: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12530. Please call the Information Line for up-to-date information on this meeting. Agenda: On April 26, 2001, the committee will consider the safety and efficacy of new drug application (NDA) 21-144, Ketek TM (telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the treatment of bacterial respiratory infections. Procedure: Interested persons