Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019

Commentary on Bertagnolli et al.: Leveraging electronic health record data for clinical trials—a brave new world

(2020) Joseph S Ross et al.   Clinical Trials

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

(2020) Audrey D. Zhang et al.   JAMA Network Open

Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products

(2020) Sanket S. Dhruva et al.   MAYO CLINIC PROCEEDINGS

Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts

(2018) Joshua D. Wallach et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Real-World Evidence — What Is It and What Can It Tell Us?

(2016) Rachel E. Sherman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Margaret A. Hamburg, MD, Reflects on 6 Years at FDA

(2015) Rita Rubin   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

(2015) Bo Wang et al.   BMJ-British Medical Journal

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

(2015) Bo Wang et al.   BMJ-British Medical Journal

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

(2014) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Systematic Review: Reliability of Compendia Methods for Off-Label Oncology Indications

(2013) Amy P. Abernethy   ANNALS OF INTERNAL MEDICINE

Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer

(2011) Aaron S. Kesselheim   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION