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Be careful what you say to the press, warns Administration.
February 3, 2010
By: TOM BRANNA
Editor
The Food and Drug Administration has issued a warning letter to Dr. Leslie Baumann, a dermatologist and clinical researcher in Miami Beach. FDA took umbrage with the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved.
Dr. Baumann’s comments in the media in 2007 violated restrictions on drug promotion, according to the letter; the agency asked Dr. Baumann to explain how she intended to prevent similar violations in the future.
According to The New York Times, this is the first time the agency has warned an individual investigator — a medical researcher who oversees a clinical trial — for apparently promoting an unapproved drug.
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