Off-Label Marketing's Audiences: The 21st Century Cures Act and the Relaxation of Standards for Evidence-Based Therapeutic and Cost-Comparative Claims
Author:
Publisher
Cambridge University Press (CUP)
Subject
Law,General Medicine,Health (social science)
Link
http://journals.sagepub.com/doi/pdf/10.1177/0098858818789420
Reference10 articles.
1. Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices;Abbott;Duke L.J.,2014
2. What Ever Happened to FDAMA Section 114? A Look back after 10 Years
3. FDA: Evidentiary standards for drug development and approval
4. Regulating Off-Label Drug Use — Rethinking the Role of the FDA
5. Off-Label Prescribing: A Call for Heightened Professional and Government Oversight
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1. The Opioid Crisis: The War on Drugs Is Over. Long Live the War on Drugs;Annual Review of Criminology;2023-01-27
2. Off-Label Use of Medicines: A Comparative Study on the Regulation of Medicinal Products in Selected European Union Member States;European Journal of Risk Regulation;2020-12-02
3. 21st Century Cures for the Opioid Crisis: Promise, Impact, and Missed Opportunities;American Journal of Law & Medicine;2018-05
4. Real-World Evidence in the Real World: Beyond the FDA;American Journal of Law & Medicine;2018-05
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