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Chart: FDA Advisory Committee Meetings – For info, visit www.fdaadvisorycommittee.com

Executive Summary

FDA Advisory Committee Meetings - For info, visit www.fdaadvisorycommittee.com



FDA Advisory Committee Meetings - For info, visit www.fdaadvisorycommittee.com

Topic

Indication/Discussion

Advisory Committee

Date

Biogen Amevive

Treatment of moderate to severe chronic plaque psoriasis

Dermatologic & Ophthalmic Drugs

May 23

Wyeth-Lederle Prevnar

Prevention of acute otitis media

Vaccines and Related Biological Products

May 21

GlaxoSmithKline Lymerix

FDA update on Lyme disease vaccine

Vaccines and Related Biological Products

May 21

Lipha acamprosate

Maintenance therapy for alcohol abstinence

Psychopharmacologic Drugs

May 10

Gene transfer vectors

Inadvertant germ line transmission, ooplasm transfer and other topics

Biological Response Modifiers

May 9-10

Food effect guidance

Food effect studies, ANDA blend uniformity analysis, other topics

Pharmaceutical Science

May 7-8

GlaxoSmithKline Lotronex

Discussion of risk management issues for withdrawn drug

Pharmaceutical Science/Drug Safety & Risk Management Subcommittee; Gastrointestinal Drugs

April 23

Schering-Plough Claritin OTC

Rx to OTC switch for allergic rhinitis and chronic idiopathic urticaria

Nonprescription; Dermatologic & Ophthalmic; Pulmonary & Allergy Drugs

April 22

Merck Cozaar

Treatment of type 2 diabetic patients with nephropathy

Cardiovascular & Renal Drugs

April 12

ViroPharma Picovir

Treatment of viral respiratory infection in adults

Antiviral Drugs

March 19

Colorectal cancer agents

Standards, trial designs for chemopreventive agent development

Gastrointestinal Drugs

March 19

Allergen extracts

Recombinant allergen regulations; glycerol in allergen extracts

Allergenic Products

March 15

Blood safety

Percutaneous exposure of blood and plasma donors; nucleic acid testing for whole blood

Blood Products

March 14-15

Corixa Melacine

Phase III study design in adjuvant treatment of melanoma.

Oncologic Drugs

Feb. 27

Meeting completed. Now available on videotape or webcast archive.

To purchase Webcasts of upcoming meetings, visit our new Website at www.fdaadvisorycommittee.comor email [email protected]. For videotapes or videoconferencing, call Tom Espina at (301) 664-7211 or email [email protected].

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