OFF-LABEL USE DATA IN "INTERMEDIATE" DRUG LABELING OFFERS POTENTIAL COMPROMISE BETWEEN INDUSTRY, CLINICIANS AND FDA, ATTORNEY COOPER SUGGESTS AT FDLI
Executive Summary
Co-development by pharmaceutical companies and FDA of hybrid labeling for off-label uses may be one way to satisfy the objectives of industry, clinicians and FDA regarding unapproved uses of drugs, Williams & Connelly partner Richard Cooper proposed May 24 at the Food & Drug Law Institute's Pharmaceutical Update '94 in Washington, D.C.
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