BIO Online Learning

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

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
Course Price:
$200 USD
BIO Member Price:
$160 USD
Course Length:
30 minutes
Course Level:
Introductory
Course Format:
On-Demand
Related Courses
FLIP

Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.

FLIP

What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning?  Learn more in this pub planning module.

FLIP

How should reprints with off-label information be issued once they have appeared in peer-reviewed medical journals? Learn the FDA regs and more?

FLIP

What are the three basic requirements for press releases?  How do you know whether a press release  is fairly balanced?    Learn the FDA regs and more.