NEWS - FDA gives advice on divulging risks

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Wall Street Journal

MAY 27, 2009.

JENNIFER CORBETT DOOREN

FDA Gives Advice on Divulging Risks

The Food and Drug Administration issued proposed advertising

guidelines for drug and medical-device makers, with suggestions on

ways to present risk information to consumers and health-care

professionals.

The draft guidelines, posted Tuesday on the agency's Web site, aren't

binding, but they offer several ways that the industry can avoid

running afoul of its rules. The FDA said the omission or minimization

of risk information is the most frequent violation cited in dozens of

enforcement or warning letters each year.

The guidelines suggest a product that requires monthly blood tests to

check for liver damage should state that in clear language rather than

using language such as the need for " certain monitoring. "

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