Life sciences partner Kellie Combs (Washington, D.C.) was quoted in a March 1 Pharmacy & Therapeutics article that examines whether the U.S. Food and Drug Administration (FDA) will relax existing drug and device communication rules.
Ms. Combs, who testified at an FDA hearing on behalf of the Medical Information Working Group, a coalition of 14 drug and device companies, notes the questions from the FDA panel made clear that officials at the agency recognize that there is value in off-label communications and that additional clarity and flexibility are needed.
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