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MANAGING RISKS OF OFF-LABEL PROMOTION AND CONTINUING MEDICAL EDUCATION The FDA Regulatory and Compliance Symposium Annen

MANAGING RISKS OF OFF-LABEL PROMOTION AND CONTINUING MEDICAL EDUCATION The FDA Regulatory and Compliance Symposium Annenberg Hall Harvard University . Arthur N. Levine Arnold & Porter LLP. August, 2005. The Basic Rules. FDA approved labeling (the PI) is the regulatory point of reference

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MANAGING RISKS OF OFF-LABEL PROMOTION AND CONTINUING MEDICAL EDUCATION The FDA Regulatory and Compliance Symposium Annen