Biomedical Market Newsletter articles from October 2002

Biomedical Market Newsletter archives from October 2002

FDA conducts survey on reuse of single-use devices in hospitals. (Breaking News).
October 31, 2002... 24.2% of all US hospitals reuse SUDs, while 45.2% of large-sized hospitals reuse SUDs. As part of its study of the reuse and reprocessing of single-use-devices (SUDs), the FDA has sponsored a telephone survey of all hospitals on SUD...

BD consumer healthcare introduces shortest insulin pen needle ever in the US. (Breaking News).(Brief Article)
October 31, 2002... BD, a leading insulin needle manufacturer, announced the launch of the BD Ultra-FineTM III Mini Pen Needle, a significant advance in insulin injection technology. The shorter length eliminates need to "pinch up" skin when injecting. According...

New FDA commissioner to be sworn in. (Breaking News).(Brief Article)
October 31, 2002... NEWS BULLETIN--President Bush's announced nominee, Dr. Mark McClellan, will be sworn in as FDA commissioner on Nov. 8, 2002, officials announced.

Discovery Health Channel features profile of BB King premiering Nov. 18 during diabetes awareness month. (Breaking News).(Brief Article)
October 31, 2002... BB King is part of a special series called BEATING DIABETES. Produced by the Discovery Health Channel in cooperation with the American Diabetes Association (ADA), the series promises to bring viewers up to the front lines of the fight against...

DHHS welcomes passage of device user fee law. (Breaking News).
October 31, 2002... Oct. 18, 2002--DHHS officials said today they welcome the passage of legislation that would provide the Food & Drug Administration's (FDA) device review program with the same type of successful funding system that has been used over the last...

$5.2 mln awarded for research to increase organ donation rates. (Breaking News).
October 31, 2002... Sept. 27, 2002--HHS Secretary Tommy G. Thompson today announced 16 grants worth $5.2 mln for research that will test medical strategies and outreach efforts intended to increase the number of organ and tissue donors. The grants are funded...

President Bush signs the device user fee law. (Breaking News).(Transcript)
October 31, 2002... Announces Action in His Weekly Radio Address. OCT. 26, 2002 -- CRAWFORD TX -- America's health care system has advantages no other nation can match, but also challenges we cannot ignore. The quality of American medicine is excellent, yet...

Medical device user fee & Modernization Act of 2002 signed into law. (Breaking News).
October 31, 2002... Frequently Asked Questions The Medical Device User Fee & Modernization Act of 2002, amending the Federal Food, Drug & Cosmetic Act, was signed by President Bush on Oct. 26, 2002, and is now law. BACKGROUND What is the Medical...

Passage of landmark FDA reforms, senate confirmation of McClellan as FDA commissioner, lauded by AdvaMed. (Breaking News).
October 31, 2002... OCT.18, 2002 -- WASHINGTON DC -- AdvaMed officials observed today that the US House and Senate "have acted decisively to improve Americans' access to innovative medical technologies." "Congress has made a difference for patients and...

Study claims new drugs save health care dollars. (Breaking News).
October 31, 2002... OCT. 04, 2002 -- WASHINGTON DC -- A new study presented on Capitol Hill today claims that using newer medicines in the place of older medicines reduces overall health care spending--and that the savings are greatest among the Medicare...

Tips from FDA on selecting a third party reprocessor for single-use devices. (Breaking News).(Brief Article)
October 31, 2002... When selecting a third-party reprocessor of single-use devices (SUDs), the FDA suggests you talk with other hospitals to determine their experiences with third-party reprocessors and arrange to visit the reprocessor's facilities. In...

FDA advice on devices & helpful hints on PMAs. (Breaking News).
October 31, 2002... OCT. 31, 2002 -- WASHINGTON DC -- Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human...

News bulletin: FDA announces complications related to the use of bone cement in vertebroplasty & kyphoplasty procedures. (Breaking News).
October 31, 2002... OCT. 31, 2002 -- WASHINGTON DC -- This notification is to inform you about reports related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine, using surgical procedures known as...

New study reveals that 31% of e-mail addresses are changed annually. (Marketing & PR).
October 31, 2002... E-mail users lose 53% of relationships, on average, after switching e-mail addresses. A new study released Oct. 2002, indicates that e-mail addresses are changed at the rate of 31% annually, causing 53% of those consumers to lose touch...

FDA deputy commissioner presentation at financial times of London global pharmaceutical conference. (Drug Discovery: part 4).(Transcript)
October 31, 2002... Nov. 6, 2002 (advanced copy) It's a pleasure to be here and participate in this truly global exploration of the latest trends in the pharmaceutical field by some of the most distinguished experts and pacesetters in the industry. My own...

Reuse CD ROM is now available. (Market Research Studies).(Brief Article)
October 31, 2002... The FDA Center for Devices & Radiological Health developed a CD ROM entitled: "An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals." While supplies last, a free copy of the CD-ROM is available by...

President takes action to lower prescription drug prices. (Breaking News).(Transcript)
October 31, 2002... Transcript of Remarks by President Bush Oct. 21, 2002; 8:33 A.M. EDT THE PRESIDENT: Good morning. For more than a year, the Federal Trade Commission has investigated delays and abuses in the process of bringing generic drugs to the market....

Presidential action of Oct. 21. (Breaking News).
October 31, 2002... * President Bush announced a new rule to lower prescription drug costs for mlns of Americans by improving access to generic drugs, which are safe and effective and can be much less costly alternatives to brand-name prescription drugs. The...

Return of mega deals boost already buoyant pharmaceutical sector M&A activity. (Mergers & Acquisitions).
October 31, 2002... PricewaterhouseCoopers survey released Oct. 4 shows that average deal size fell significantly. Deal activity remained buoyant in the pharmaceutical sector in the first half of 2002 relative to most other industries, a new mergers &...

15% increase in health care costs forecast. (Market Research Studies).
October 31, 2002... Highest Percentage increase in Over a Decade Employees Will Pay More in Out-of-Pocket Costs. For the fourth consecutive year, large employers will experience a double-digit increase in their health care costs, indicates preliminary results...

Analysis & comments on OIG compliance guidance for pharmaceutical manufacturers. (OIG Guidance).
October 31, 2002... Several new surprises are included. On Oct. 1, 2002, the US Department of Health & Human Services Office of the Inspector General (OIG) released its Draft Compliance Program Guidance for Pharmaceutical Manufacturers. Inspector General...

FDA effect of user fees on drug approval times, withdrawals & other agency activities. (Market Research Studies).
October 31, 2002... Part 2; Continued From Sept. 30 issue. Report to the Chairman Committee on Health, Education, Labor & Pensions US Senate Sept. 17, 2002 US General Accounting Office Washington DC Despite the growth of user fees, user fee...

Inspector general releases draft fraud & abuse guidance for pharmaceutical manufacturers. (OIG Guidance).
October 31, 2002... RELEASED: Oct. 01, 2002 DEADLINE: Dec. 01, 2002 DHHS Office of Inspector General Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers AGENCY: Office of Inspector General, HHS. ACTION: Notice & comment...

371 biotech medicines in testing offer hope of new treatments for nearly 200 diseases. (OIG Guidance).
October 31, 2002... OCT. 21, 2002 -- WASHINGTON DC -- Over 250 mln people have already benefited from medicines and vaccines developed through biotech, and a new survey by the Pharmaceutical Research & Manufacturers of America (PhRMA) identifies 371 more biotech...