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Division of Drug Marketing, Advertising, and Communications Enforcement Webinar

Division of Drug Marketing, Advertising, and Communications Enforcement Webinar. Sangeeta Vaswani Chatterjee, Regulatory Counsel Team Leader Marissa Chaet Brykman, Regulatory Counsel Bryant Godfrey, Regulatory Counsel Ernest Voyard, Regulatory Counsel August 25, 2011. Mission.

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Division of Drug Marketing, Advertising, and Communications Enforcement Webinar

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  1. Division of Drug Marketing, Advertising, and CommunicationsEnforcement Webinar Sangeeta Vaswani Chatterjee, Regulatory Counsel Team Leader Marissa Chaet Brykman, Regulatory Counsel Bryant Godfrey, Regulatory Counsel Ernest Voyard, Regulatory Counsel August 25, 2011

  2. Mission "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."

  3. Warning Letters Bromday Multikine Vyvanse Untitled Letters Acanya Atelvia Focalin XR KRX-0401 Pexeva Solaraze Trisenox Enforcements

  4. Violations include: • Omission/Minimization of Risk • Unsubstantiated Claims • Unsubstantiated Superiority Claims • Broadening of Indication • Overstatement of Efficacy • Omission of Material Facts • Promotion of an Investigational Drug • Misleading Claims (dosing, compliance) • Failure to Submit Under Form FDA-2253

  5. Thank you! • Webinar Feedback • CDERDDMACenforceweb@fda.hhs.gov

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