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Scientific Exchange/Safe Harbor
Overview of key elements of scientific exchange based on several FDA guidance documents including responding to unsolicited requests for off-label information about prescription drugs and medical devices and distributing scientific and medical publications on unapproved new uses – recommended practices. Covers range of activities including definition of scientific exchange and safe harbor, general guidelines for compliant content, responding to unsolicited questions for off-label, and distribution of scientific and medical publications on unapproved new uses.
Takeaways
- Scientific Exchange is an FDA regulation that is codified in the Code of Federal Regulations, or CFR, as Section 312.7(a)
- Scientific exchange occurs when companies exchange medical and scientific information or data in a non-promotional context, or in response to unsolicited questions from healthcare professionals, healthcare organizations, patient advocacy groups, and third party media
- When this exchange is non-promotional in nature, it is regarded as acceptable from an enforcement standpoint and is known unofficially as a “safe harbor.”
- The FDA has issued several guidances relating to scientific exchange/safe harbor, including responding to unsolicited questions for off-label, and distribution of scientific and medical publications on unapproved new uses
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