Biomedical Market Newsletter articles from March 2001

Biomedical Market Newsletter archives from March 2001

Guidance On Acceptance Of Foreign Clinical Studies Released By FDA : Ethical principles clarified, public comments requested.
March 31, 2001... On March 13, 2001, the US FDA released final guidance to clarify the ethical principles with which a company must comply, before FDA will accept a foreign clinical study that was not conducted under an FDA-approved IND or IDE (investigational...

Automated External Defibrillators Are Efficient/Effective For Responding To Cardiac Arrest.
March 31, 2001... MARCH 7 2001 -- CHICAGO IL USA-- The automated external defibrillator (AED) represents an efficient method for delivering defibrillation to people who suffer cardiac arrest outside a hospital, a new report claims. Studies on its use by...

Trends In Screening For Colorectal Cancer.(Statistical Data Included)
March 31, 2001... Release: March 9, 2001 US Centers for Disease Control & Prevention Atlanta GA USA Colorectal cancer is the second leading cause of cancer-related death in the US (1). An estimated 135,400 new cases and 56,700 deaths from colorectal...

US Cancer Facts & Figures.(Statistical Data Included)
March 31, 2001... JAN 4 2001 -- NEW YORK NY -- "Cancer Facts & Figures 2001," the American Cancer Society's annual estimates of expected numbers of new cancer cases and deaths, and related publications, present new nationwide data, highlighted below: -- An...

ESRD Hospital Outpatient Lab Tests Improperly Billed, Says OIG Report.(end-stage renal disease, Office of the Inspector General)
March 31, 2001... JAN 31 2001 -- WASHINGTON DC -- A new DHHS Office of the Inspector General (OIG) final report points out that, based on a statistical sample, approx. $6.1 min was improperly paid to hospital labs for services provided to ESRD beneficiaries...

Cancer Vaccine Markets Set to Explode Upon Commercialization of' New Drugs.
March 31, 2001... SAN JOSE CA USA -- JAN 31 2001 -- Commercial approval of cancer vaccines is one of the most eagerly anticipated progressions in modern healthcare. With a patient population of over 8 min in the US alone, physicians are anxious to try anything...

US Cancer Vaccines Market.
March 31, 2001... EXECUTIVE SUMMARY Market Overview & Introduction Cancer is defined as the uncontrolled growth of abnormal cells derived from normal tissues, which eventually can cause death by spreading from the site of origin to other sites. ...

Medical Equipment & Supplies Overpayments Alleged By OIG.(Office of the Inspector General)
March 31, 2001... FEB 2 2001 -- WASHINGTON DC -- In 1999, Medicare beneficiaries (patients) paid $41 min above the Medicare allowed amounts for medical equipment and supplies, claims the DHHS Office of the Inspector General (OIG). Most surveyed...

Organ Transplant Waiting List Continues To Jump, Says UNOS.(United Network for Organ Sharing )(Statistical Data Included)
March 31, 2001... FEB 23 2001 -- RICHMOND VA USA-- The number of patients waiting for organ transplants increased from 21,914 in 1990 to 72,110 by yearend 1999, notes a new report released by the United Network for Organ Sharing (UNOS).

Online ad firm sees best Growth from E-mail ads.
March 31, 2001... FEB 13 2001 -- SAN FRANCISCO CA USA -- The head of one of the largest Internet advertising firms claims that despite the industry's current weakness, he is still optimistic on the outlook for Internet advertising in general, and especially...

Medicare Reimbursement for Critical Care Services.
March 31, 2001... FEB 28 2001 WASHINGTON DC -- The US Health Care Financing Administration (HCFA), as well as local carriers and practitioners, are voicing concerns about exploitation of critical care codes. However, based on a DHHS Office of the Inspector...

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA) : Final Guidance for Industry & FDA CDRH.(Center for Devices & Radiological Health)
March 31, 2001... Document issued on: February 28, 2001 This document supersedes: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Guidance for Industry and CDRH Staff, February 19, 1998) US DHHS Food & Drug Administration...

Medical Device Regulatory & Marketing Requirements Worldwide-2001[TM].
March 31, 2001... International Trade Administration US Dept of Commerce Washington DC Biomedical Market Newsletter[TM] Costa Mesa CA USA ARGENTINA Updated 12/08/00 The National Administration of Drugs, Foodstuffs and Medical Technology...

FDA PMA Approvals [High-Tech Products] : September 2000 - January 2001.
March 31, 2001... JANUARY 2001 PMA ORIGINAL APPROVALS Quintiles Inc Arlington VA 22209 P980044 01/24/01 SUPARTZ[TM] Dispo Approval for SUPARTZ[TM] Dispo. Device is indicated for treatment of pain in osteoarthritis (OA) of knee in patients who...

Update Notice.(Correction Notice)
March 31, 2001... The website address for Global Healthcare Exchange recently changed from what was listed in the Feb. 28, 2001 issue of BMN, and is now: http://www.ghx.com