Article: FDA issues draft guidelines on drug-eluting stents.(Medical Devices)

Article: Drug-eluting stent safety triggers special FDA advisory panel.(News Wire)
Healthcare Purchasing News;  October 1, 2006 ;     339 words ......makers of the two FDA-approved drug-eluting stents-Cypher, a sirolimus-eluting...stents. The FDA also signaled...patients with drug-eluting stents. The hypothesis...Plavix. The FDA said it believes that coronary [drug-eluting stents] ...

Article: New Safety Concerns Have Begun to Erode the Market Share of Drug-Eluting Stents.
Business Wire;  May 24, 2007 ;     700+ words ......generation drug-eluting stents that are beginning...generation of drug-eluting stents has prompted...currently available drug-eluting stents? Will the recent...concerns that drug-eluting stents are associated...manufacturers of other ...

Article: FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October.
Business Wire;  August 21, 2007 ;     436 words ......Food and Drug Administration (FDA) that an Advisory Panel will review...application for the Endeavor[R] Drug Eluting Coronary Stent in October. The FDA will announce the date and the...clinical data submitted to the FDA, with data from the largest, most...the safety and efficacy of a ...

Article: FDA PANEL TO REVIEW MEDTRONIC'S ENDEAVOR DRUG ELUTING STENT.
Biotech Equipment Update;  October 1, 2007 ;     440 words ......Food and Drug Administration (FDA) that an Advisory Panel will review...application for the Endeavor Drug Eluting Coronary Stent in October. The FDA will announce the date and the...clinical data submitted to the FDA, with data from the largest, most...the safety and efficacy of a ...

Article: FDA, SEC link up on false statements to public.
Warning Letter Bulletin;  March 8, 2004 ;     700+ words ...Dear Reader, FDA and the Securities and Exchange Com-mission have developed a closer partnership, whereby FDA will provide SEC with information about potential...executives concealed the fact from investors that FDA would not be approving its drug, Erbitux...

Article: Drug companies drain scientific brains from FDA, leaving less confident staff.(FDA management)(United States. Food and Drug Administration)
Adverse Event Reporting News;  June 17, 2008 ;     482 words ...As drug companies siphon off FDA's most experienced scientists, they leave...say in article in the June 4 USA Today. FDA's leadership is scrambling to recruit a...drug regulators, as the average age of FDA's 10,100-person work force reaches 54...

Article: Drug-eluting stents.(AHRMM Ideas)
Healthcare Purchasing News;  June 1, 2004 ;     700+ words ......April 2003, the FDA approved a significant...metal stent. The drug-eluting stents approved in April...select groups. Drug-eluting stents are indicated in...technology post FDA approval, the manufacturer...for the use of drug-eluting stents. The aim ...

Article: Jurors and FDA scientists lack confidence in agency, surveys say.
Trial;  October 1, 2006 ;     700+ words ...Perceptions of the FDA--from both inside and outside the agency...of Concerned Scientists (UCS) survey of FDA scientists reveal a grim perspective of...technical information or my conclusions in an FDA scientific document. Sixty percent said...

Article: FDA (United States Food and Drug Administration)
Encyclopedia of Espionage, Intelligence, and Security;      375 words ...FDA (United States Food and Drug Administration) The Food and Drug Administration (FDA), a Department of Health and Human Services agency, regulates...over-the-counter drugs, cosmetics, and medical equipment. The FDA's reach is so extensive that one-fifth of all consumer dollars...

Article: FDA beefs up criminal enforcement with help from states' attorneys.
Inspection Monitor;  May 1, 2004 ;     700+ words ...WASHINGTON -- FDA-regulated firms might long for the days when...investigations were conducted by lawyers in FDA's Office of Consumer Litigation (OCL). That...Annual Conference here April 15. He said FDA's enforcement activities have taken a new...

Article: Industry faces more criminal charges as FDA turns to U.S. attorneys for enforcement backup.(Compliance/enforcement)
Validation Times;  April 1, 2004 ;     700+ words ...WASHINGTON -- FDA's enforcement activities have taken a new...Annual Conference here April 15. Kowal said FDA-regulated firms might long for the days when...investigations were conducted by lawyers in FDA's Office of Consumer Litigation (OCL). Now...

Article: FDA-SEC partnership raises questions about disclosure of development and trial reports.(Drug development)
Validation Times;  April 1, 2004 ;     700+ words ...WASHINGTON -- FDA's efforts to have drug and biologics makers...pose enforcement actions from two agencies. FDA and SEC solidified their relationship February...measures establish a centralized procedure for FDA to refer to the SEC instances of false and...

Article: Medtronic Starts U.S. Arm of Global Study Comparing Safety of Endeavor(R) and Cypher(R) Drug-Eluting Stents.
Business Wire;  July 30, 2008 ;     700+ words ......R]) and Cypher([R]) drug-eluting stents on key safety metrics...primarily on the safety of drug-eluting stents, which remains an important...Drug Administration (FDA) with U.S.-specific...stent, which received FDA approval Feb. 1. The...safety and efficacy of ...

Article: Spreading the word: FDA as health educator. (column)
FDA Consumer;  February 1, 1988 ;     700+ words ...Spreading the Word: FDA as Health Educator FDA is probably best known for its role in removing potentially dangerous...products from the marketplace. In fiscal year 1987 alone, for example, FDA monitored approximately 2,400 recalls and instituted 200 seizueres...