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Pharmaceutical companies have often been uncertain about how to meet their regulatory obligations while engaging in the new social media forums favored by consumers and physicians alike. FDA has released its first guidance addressing this topic since its 2009 hearings on the subject. The guidance addresses how sponsors can fulfill their requirement to file all material at the time of first use (the 2253 requirement) while engaging in real-time conversations.
This presentation examines key aspects of the guidance including:
* Status of user-generated content (UGC) and companies' reporting obligation for UGC
* Ability to meet 2253 filing requirements in the context of real-time conversations
* Implications of the guidance for filing online promotional materials other than social media
* Some open questions left unanswered by the guidance