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U.S. Constitution vs. FDA: Off-Label Discussions No Longer Faux Pas?

By Kenneth Alan Totz, DO, JD, FACEP | on June 20, 2019 | 0 Comment
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Dr. Totz is facility medical director at First Choice Emergency Room at Adeptus Health in Texas.

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Explore This Issue
ACEP Now: Vol 38 – No 06 – June 2019

References

  1. Ventola CL. Off-label drug information: regulation, distribution, evaluation, and related controversies. P T. 2009;34(8):428-440.
  2. Adams RK, Crudele L. The eroding off-label drug use promotion prohibition. J Health Life Sci Law. 2019;12(2):1-20.
  3. Sullivan T. US v. Caronia, one year later: FDA’s position on off-label promotion remains the same, but changes are looming. May 6, 2018. Policy & Medicine website. Accessed April 10, 2019.
  4. Amarin Pharma, Inc. v. FDA. Harvard Law Rev. 2016;29(7):2021-2028.

Pages: 1 2 | Single Page

Topics: FDAoff-labelPrescription Drugs

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