scholarly journals Inclusion of Training Patients in US Food and Drug Administration Premarket Approval Cardiovascular Device Studies

2011 ◽  
Vol 171 (6) ◽  
Author(s):  
Connie E. Chen ◽  
Sanket S. Dhruva ◽  
Lisa A. Bero ◽  
Rita F. Redberg
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Premarket Approval

Wyeth v. Levine: Challenging Implied Pre-emption for drugs

2009 ◽  
Vol 37 (3) ◽  
pp. 527-530
Author(s):  
Pooja Nair
Keyword(s):  
Supreme Court ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
State Law ◽  
Drug Labeling ◽  
The Supreme Court ◽  
Premarket Approval ◽  
Tort Claims

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015

Ophthalmology ◽  
2017 ◽  
Vol 124 (8) ◽  
pp. 1237-1246
Author(s):  
Anand D. Gopal ◽  
Vinay K. Rathi ◽  
Christopher C. Teng ◽  
Lucian Del Priore ◽  
Joseph S. Ross
Keyword(s):  
Life Span ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Premarket Approval

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014

2017 ◽  
Vol 156 (2) ◽  
pp. 285-288 ◽  
Author(s):  
Vinay K. Rathi ◽  
Bo Wang ◽  
Joseph S. Ross ◽  
Nicholas S. Downing ◽  
Aaron S. Kesselheim ◽  
...  
Keyword(s):  
High Risk ◽  
Drug Administration ◽  
Clinical Evidence ◽  
Food And Drug Administration ◽  
Premarket Approval
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