New and incremental FDA black box warnings from 2008 to 2015-Reference-Cited by-同舟云学术

New and incremental FDA black box warnings from 2008 to 2015

Published:2017-12-17 Issue:2 Volume:17 Page:117-123
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Solotke Michael T.¹,Dhruva Sanket S.²³⁴,Downing Nicholas S.⁵,Shah Nilay D.⁶,Ross Joseph S.²⁷⁸⁹

Affiliation:

1. School of Medicine, Yale University, New Haven, CT, USA

2. Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA

3. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA

4. Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA

5. Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA

6. Division of Health Care Policy and Research and Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

7. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA

8. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA

9. Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, CT, USA

Funder

National Institute of Diabetes and Digestive and Kidney Diseases

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2018.1415323

Reference20 articles.

1. U.S. Food and Drug Administration. Guidance for industry: warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products – content and format. 2011 Oct 11. [cited 2017 Dec 08]. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm075096.pdf

2. Evaluation of FDA safety-related drug label changes in 2010

3. Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012

4. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

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