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Best Practices in Stakeholder Involvement

2. Challenges Drug Products. 10,000 products marketed in USBrandedGenericOver-the-counterFor wide variety of uses and conditionsLife savingPreventativeSymptomaticOver 900 safety-related label changes/yearWarnings, precautions, adverse events. 3. Challenges Drug Products. Everyone uses

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Best Practices in Stakeholder Involvement

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    1. 1 Best Practices in Stakeholder Involvement Paul J. Seligman, M.D., M.P.H. Associate Director, Safety Policy & Communication Center for Drug Evaluation and Research/FDA PATHS Annual Meeting September 2008

    2. 2 Challenges – Drug Products 10,000+ products marketed in US Branded Generic Over-the-counter For wide variety of uses and conditions Life saving Preventative Symptomatic Over 900 safety-related label changes/year Warnings, precautions, adverse events

    3. 3 Challenges – Drug Products Everyone uses drugs Language Health literacy Information everywhere Professional label Consumer Medication Information Patient Package Inserts Medication Guides FDA Alerts

    4. 4 Reaching the Audience The Role of Partners MedWatch Patient Safety News Meeting the needs of ‘busy’ healthcare professionals and their patients Providing easy and quick access to timely and actionable information

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