Last Updated: 09/26/2026
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Found 20 publications
Evidence Generation for Drugs and Biological Products isn't Magic or Myth.
Journal: Clinical pharmacology and therapeutics
Published: October 23, 2024
Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.
Journal: JAMA network open
Published: May 31, 2022
Real-World Evidence - Where Are We Now?
Journal: The New England journal of medicine
Published: April 29, 2022
Summary of Literature on Pediatric Real-world Evidence and Effectiveness.
Journal: JAMA pediatrics
Published: July 12, 2021
FDA Breakthrough Therapy Designation-Trial Design and More - Commentary.
Journal: Clinical pharmacology and therapeutics
Published: April 30, 2021
Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.
Journal: Journal of the American Society of Nephrology : JASN
Published: October 20, 2020
Randomized, observational, interventional, and real-world-What's in a name?
Journal: Pharmacoepidemiology and drug safety
Published: June 22, 2020
Clarifications regarding the authority and role of FDA in drug approval.
Journal: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Published: December 08, 2019
The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence.
Journal: Clinical pharmacology and therapeutics
Published: December 28, 2018
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.
Journal: JAMA
Published: August 15, 2018
Breakthrough-Therapy Designation - An FDA Perspective.
Journal: The New England journal of medicine
Published: April 12, 2018
The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety.
Journal: Advances in experimental medicine and biology
Published: September 17, 2015
Last Updated: 09/26/2026