Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel-Reference-Cited by-同舟云学术

Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel

Published:2022-04-18 Issue:6 Volume:111 Page:1307-1314
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Dhruva Sanket S.¹²³,Darrow Jonathan J.⁴⁵,Kesselheim Aaron S.⁴,Redberg Rita F.¹²⁶

Affiliation:

1. University of California, San Francisco School of Medicine San Francisco California USA

2. Philip R. Lee Institute for Health Policy Studies University of California San Francisco California USA

3. Section of Cardiology Department of Medicine San Francisco Veterans Affairs Medical Center San Francisco California USA

4. Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women’s Hospital and Harvard Medical School Boston Massachusetts USA

5. Department of Law and Taxation Bentley University Waltham Massachusetts USA

6. Division of Cardiology Department of Medicine San Francisco School of Medicine University of California San Francisco California USA

Funder

Greenwall Foundation

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2583

Reference51 articles.

1. New FDA Breakthrough-Drug Category — Implications for Patients

2. The FDA Breakthrough-Drug Designation — Four Years of Experience

3. Breakthrough Medical Devices and the 21st Century Cures Act

4. Early experience with the FDA’s Breakthrough Devices program

5. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

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