Biomedical Market Newsletter articles from November 2002

Biomedical Market Newsletter archives from November 2002

Dr. Mark McClellan becomes the new FDA Commissioner. (Breaking News).
November 20, 2002... Accomplished background & likeable personality are good news for the medical industry On Nov. 14, 2002, Dr. Mark B. McClellan was officially sworn in by Vice President Cheney as the new permanent Commissioner of the US Food & Drug...

FDA approves heart assist pump for permanent use. (Breaking News).
November 20, 2002... NOV. 6, 2002 -- The FDA approved a heart assist pump to be implanted permanently in certain terminally ill patients who are not eligible for heart transplant. The device, called HeartMate, is a left ventricular assist device (LVAD) made by...

1st speech presented by new FDA Commissioner McClellan at FDA groundbreaking ceremony. (Breaking News).
November 20, 2002... Washington DC Nov. 15, 2002 (condensed version) Yesterday, the Vice President swore me in to the most important job I have ever had: Commissioner of Food & Drugs. And I am very pleased that my inaugural event as Commissioner is the...

Medical Industry Conference Calendar Directory-2003[TM].
November 20, 2002... Featuring brief profiles of almost 2,000 medical meetings worldwide in dozens of countries. Published exclusively by: Biomedical Market Newsletter[R] 3237 Idaho Place * Costa Mesa CA USA 92626-2207 (714) 434-9500 phone * (714) 434-9755...

Medical Device User Fee Rates & interim procedures announced by the FDA $25.125 m/n projected to be raised in FY2003. (Breaking News).
November 26, 2002... On Nov. 21, 2002, the US Food & Drug Administration published its new Medical Device User Fee Rates for the 2003 fiscal year, in the Federal Register (Vol. 67, No. 225; pp. 70228-70229). An estimated $25,125,000 is projected to be raised by the...

1st Amedment & the FDA; which takes precedence? Medical Marketing claims & DTC advertising activities analyzed by the US Federal Trade Commission. (Market Research Studies).
November 26, 2002... In the Matter of the FDA Request for Comment on First Amendment Issues Docket No. 02N-0209 Comments of the Staff of: Bureau of Economics Bureau of Consumer Protection Office of Policy Planning Federal Trade Commission J. Howard...

Competition in the pharmaceutical marketplace: a review of the FTC report "generic drug entry prior to patent expiration". (Guest Editorial).
November 26, 2002... Rep. Henry A. Waxman, D-CA US House of Representatives Washington DC The Hatch-Waxman Amendments set out to lower drug prices by encouraging generic competition in the prescription drug marketplace. At the same time, the law protected...

Health care & competition in the 21st century: everything old is new again. (Guest Editorial).
November 26, 2002... Prepared Remarks of Timothy J. Muris * Chairman US Federal Trade Commission Before the 7th Annual Competition in Health Care Forum Chicago, Illinois Nov. 7, 2002 * This speech does not necessarily reflect the views of the...

Direct-to-consumer advertising strengthens our health care system: encourages informed discussions between patients & physicians. (Market Research Studies).
November 26, 2002... Pharmaceutical Research & Manufacturers of America Washington DC While debate over prescription drug advertising, otherwise known as direct-to-consumer advertising (DTCA) is taking place now, DTCA of prescription drugs is not new. The...

Medical advertising laws & regulations: disclaimers will not cure the inherently misleading nature of off-label promotion. (Guest Editorial).
November 26, 2002... Oct. 28, 2002; Docket No. 02N-0209 Comments of Sidney M. Wolfe, MD Larry D. Sasich, Pharm. D., MPH Public Citizen Health Research Group Allison M. Zieve David C. Vladeck Public Citizen Litigation Group Washington DC ...

FDA Bioterrorism Act website is online. (Market Research Studies).
November 26, 2002... NOV. 7, 2002 -- FDA has added a new page to its existing bioterrorism website to provide information on the agency's efforts, related to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). ...