Disclosing accelerated approval on direct-to-consumer prescription drug websites
Author:
Affiliation:
1. US Food and Drug Administration; Silver Spring MD USA
Publisher
Wiley
Subject
Pharmacology (medical),Epidemiology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4664/fullpdf
Reference12 articles.
1. Federal Food, Drug & Cosmetic Act § 506(c) 2017
2. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review;Beaver;JAMA Oncol,2018
3. The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses;Prasad;JAMA Intern Med,2015
4. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration;Naci;JAMA,2017
5. Ponatinib: accelerated disapproval;Gainor;Oncologist,2015
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3. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017;JAMA Health Forum;2022-05-27
4. Potential policy reforms to strengthen the accelerated approval pathway;Journal of Comparative Effectiveness Research;2021-11
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