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Home » Store » Webinar Recordings » Off-Label Drug Promotion - Webinar CD/Transcript

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Audio CD/Transcript - Jan. 30, 2017

$287.00

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Off-Label Drug Promotion - Webinar CD/Transcript

$287.00
Webinar Recordings

Product Details

Off-Label Drug Promotion: FDA’s Recent Enforcement in the Product Promotional Arena

The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information.

Recently, the FDA’s authority to restrict off-label communications has been successfully challenged in a series of court decisions suggesting that companies may distribute truthful — non-misleading information — about off-label uses of their products without violating the FDCA.

On Nov. 9-10, 2016 the FDA held a public hearing on manufactures ability to communicate information about unapproved uses of medical products that have at least one approved or cleared indication — or “off-label communications.”

Legal expert Alan Minsk — of Arnall Golden Gregory — discusses the FDA’s latest rules on what speech is and is not protected.

In this 1-hour session you will learn about:

  • FDA’s enforcement against pre-approval promotion
  • The PhRMA/BIO principles on sharing truthful and non-misleading information
  • FDA's recent public hearing on off-label communications
  • Non-FDA-related issues to consider with off-label promotion
  • A look ahead to where might we be headed

Order today and learn about how you can promote off-label uses of your drug while remaining compliant with FDA regulations.

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