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Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

Food and Drug Administration (FDA)
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Food and Drug Administration (FDA)
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Keywords
Code of ethics
code of conduct
Food and Drug Administration (FDA)
public health
promotions
human prescriptions
animal prescriptions
GE Subjects
Cultural ethics
Media/communication/information ethics
Bioethics
Medical ethics
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Codes of Ethics
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CDER201298.pdf
Adobe PDF, 115.56 KB
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http://hdl.handle.net/20.500.12424/216126
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Abstract
"This draft guidance describes FDA’s current thinking on what the Agency considers to be interactive promotional media and outlines the considerations taken into account in determining if product communications using interactive technologies are subject to FDA’s postmarketing submission requirements. Furthermore, this draft guidance provides FDA’s recommendations for how firms can fulfill the regulatory requirement to 31 submit postmarketing promotional materials to the FDA in a practical manner to address the potential volume of real time information that is continuously posted and shared through various interactive promotional media platforms."
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Preprint
Date
2014-01
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With permission of the license/copyright holder
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