scholarly journals Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the Edwards SAPIEN™ Transcatheter Heart Valve

Circulation ◽  
2012 ◽  
Vol 125 (3) ◽  
pp. 550-555 ◽  
Author(s):  
Israel M. Barbash ◽  
Ron Waksman
Keyword(s):  
Advisory Committee ◽  
Heart Valve ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Circulatory System ◽  
Committee Meeting ◽  
Transcatheter Heart Valve ◽  
Edwards Sapien

Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting About Vorapaxar

Circulation ◽  
2014 ◽  
Vol 130 (15) ◽  
pp. 1287-1294 ◽  
Author(s):  
Nevin C. Baker ◽  
Michael J. Lipinski ◽  
Thibault Lhermusier ◽  
Ron Waksman
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Committee Meeting

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.

SUIT CLAIMS RESEARCH-HOSPITAL DOCTORS SUBMITTED PHONY BILLS TO GET U.S. FUNDS

PEDIATRICS ◽  
1995 ◽  
Vol 96 (5) ◽  
pp. A41-A41
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Controversial Issue ◽  
Criminal Investigation ◽  
Research Hospital ◽  
Medical Centers ◽  
Cardiac Procedures ◽  
Hospital Doctors ◽  
The Government

Physicians at dozens of prominent research hospitals nationwide allegedly submitted phony bills and sometimes even falsified patients' records to obtain as much as $1 billion in federal payments for sophisticated, but still experimental, cardiac procedures, a newly unsealed whistleblower suit claims. The allegations of years of systematic fraud involving as many as 130 major medical centers nationwide, accusations that already have prompted a previously reported criminal investigation, are likely to shine a spotlight on the controversial issue of which cutting-edge devices and procedures currently are, or should be, eligible for Medicare or Medicaid claims. Existing regulations say that the government generally won't pay for treatment considered to be "experimental" or for the use of medical devices that haven't been formally approved by the Food and Drug Administration...

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