US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion
Author:
Funder
Arnold Ventures
Publisher
BMJ
Reference43 articles.
1. Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics
2. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
3. US Food and Drug Administration. Frequently asked questions: breakthrough therapies. 2022. https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
4. The FDA Breakthrough-Drug Designation — Four Years of Experience
5. A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language
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1. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies;JAMA Network Open;2024-08-27
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