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Session 2 Track A-B: Overview of Recent FDA Guidances Relevant to Medical Communications
Session Chair(s)
Monica Kwarcinski, PHARMD
Vice President, Medical Affairs
Purdue Pharma L.P., United States
Over the last few years FDA has issued several draft guidances that are relevant to the practice of medical communications within industry. While these guidances are still draft they do provide FDA’s current thinking on topics such as dissemination of reprints on off-label uses or new risk information for approved drugs, responding to unsolicited requests for off-label uses of approved drugs or devices and correcting misinformation found in social media. This session will provide an overview of recent FDA guidances as well as an update on anticipated guidances on scientific exchange and dissemination of healthcare economic information.
Learning Objective : At the conclusion of this session, participants should be able to:
• Explain where to access the most current information about FDA guidances
• Describe recent FDA guidances relevant to industry medical communications
• Describe what guidances FDA is planning on developing in 2015 that impact the practice of industry medical communications
Speaker(s)
Faculty
Monica Kwarcinski, PHARMD
Purdue Pharma L.P., United States
Vice President, Medical Affairs
Faculty
Robin Whitsell
Whitsell Innovations, Inc., United States
President