Integrated Drug Reviews at the US Food and Drug Administration—Legal Concerns and Knowledge Lost-Reference-Cited by-同舟云学术

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Integrated Drug Reviews at the US Food and Drug Administration—Legal Concerns and Knowledge Lost

Published:2020-05-01 Issue:5 Volume:180 Page:629
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Herder Matthew¹²,Morten Christopher J.³,Doshi Peter⁴

Affiliation:

1. Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada

2. Department of Pharmacology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

3. Engelberg Center on Innovation Law & Policy, New York University School of Law, New York

4. Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2762578/jamainternal_herder_2020_vp_200001.pdf

Reference9 articles.

1. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study.;Silverstein;JAMA,2000

2. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib.;Hrachovec;JAMA,2001

3. Lost in transmission—FDA drug information that never reaches clinicians.;Schwartz;N Engl J Med,2009

4. The Drug Facts Box: improving the communication of prescription drug information.;Schwartz;Proc Natl Acad Sci U S A,2013

5. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.;Kesselheim;Health Aff (Millwood),2007

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1. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics;BMJ Evidence-Based Medicine;2023-03-21

2. Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: a case study of public documents;Journal of Clinical Epidemiology;2021-11

3. Exploring the Food and Drug Administration’s review and approval of Entresto (sacubitril/valsartan);Pharmacology Research & Perspectives;2021-05

4. The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs and Vaccines;CALIF LAW REV;2021

5. Corporations, high-stakes biomedical research, and research misconduct: yes they can (and sometimes do);Journal of Law and the Biosciences;2021-01

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