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Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases (Aspatore Special Report)

Product details:

Format: Book - softbound
Brand: Aspatore
Copyright: 2013
ISBN: 9780314290946
Service #: 41551860
Pages: 60
Shelf Space: 1 in.
Publication frequency: As needed
Update method: No updating

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Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases (Aspatore Special Report)

100211128

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100211128
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Navigating Recent Off-Label Promotion Developments provides feedback from some of the nation's leading legal minds on staying up-to-date with current regulations and FDA enforcement practices. Determining the allowances and limitations of off-label promotion has recently become more challenging with cases such as Caronia. Attorneys and clients alike are keeping tabs on what instances of off-label promotion are being scrutinized in order to remain in compliance and ultimately avoid prosecution. In light of this, key questions have been raised, such as:

  • What is considered “off-label promotion”?
  • What are the repercussions for those who violate government regulations?
  • What role does the First Amendment play in off-label promotion?
  • What impact have recent, noteworthy cases had on food and drug law as a whole?
  • How are the rules governing off-label promotion changing?
  • Has the FDA issued any additional guidance on the subject?
  • What issues remain unclear, despite these recent developments?
In this title, experts discuss how to differentiate between what is classified as allowable, truthful, scientific information versus prohibited off-label promotion. Additionally, the authors give tips on ways to ease client concerns during this time of uncertainty. This report offers readers an on-the-spot look at this issue as it continues to unfold.