VaxGen receives FDA warning letter

By Lisa Kerner

Erie, Pa., April 5 - VaxGen Inc. said it received a warning letter from the Office of Compliance and Biologics Quality of the Food and Drug Administration's Center for Biologics Evaluation and Research.

The letter alleges that a question and answer document distributed by the company at the 4th Annual Federal Biodefense Research meeting in October contains statements that prematurely promote VaxGen's anthrax vaccine candidate as safe and effective prior to FDA approval, a violation of the Federal Food, Drug and Cosmetic Act and related regulations, according to an 8-K report.

VaxGen has complied with the FDA's request to stop disseminating the question and answer document and expects to work with the FDA to take corrective action, according to a news release.

VaxGen is a biopharmaceutical company located in Brisbane, Calif.

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