BioCentury on BioBusiness,
Politics and Policy
FDA paints chaotic off-label picture
Monday, April 12, 1999
By Steve Usdin
WASHINGTON - Confusion over the status of regulations on the dissemination of data about off-label uses of approved products has created a legal limbo in which manufacturers of drugs, biologics and devices are adopting diverse strategies. Some have submitted off-label information to FDA for review and approval prior to dissemination, others have cited a federal judge's ruling as authority for disseminating information with accompanying disclosures, and others are completely ignoring the agency, according to an affidavit filed by the FDA last week.
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