The association between US Food and Drug Administration−expedited review designations and health plan specialty drug coverage-Reference-Cited by-同舟云学术

The association between US Food and Drug Administration−expedited review designations and health plan specialty drug coverage

Published:2023-05 Issue:5 Volume:29 Page:464-471
ISSN:2376-0540
Container-title:Journal of Managed Care & Specialty Pharmacy
language:en
Short-container-title:JMCP

Author:

Panzer Ari D¹,Ingham Michael²,Martin Silas²,Chambers James D¹

Affiliation:

1. Center for the Evaluation of Value and Risk in Health Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.

2. Janssen Scientific Affairs, LLC, Titusville, NJ.

Publisher

Academy of Managed Care Pharmacy

Subject

Health Policy,Pharmaceutical Science,Pharmacy

Reference15 articles.

1. Food and Drug Administration. Guidance for industry: Expedited programs for serious conditions—drugs and biologics [Internet]. Silver Spring, MD: FDA; 2014 May. Accessed June 15, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

2. FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

3. The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

4. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

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