Biomedical Market Newsletter articles from September 2002

Biomedical Market Newsletter archives from September 2002

President Bush announces intention to nominate new FDA Commissioner: Dr. Mark B. McClellan is currently a member of the President's Council on Economic Advisors. (Breaking New).
September 30, 2002... On Sept. 25, 2002, President George W. Bush today announced his intention to nominate Mark B. McClellan to be Commissioner of the US Food & Drug Administration. Dr. McClellan is currently a member of the President's Council on Economic...

Guidant announces results of key study in emerging field of heart attack prevention: vulnerable plaque presents significant opportunity for preventive therapy. (Breaking News).
September 30, 2002... SEPT. 27, 2002 -- Guidant Corp (NYSE & PCX: GDT), announced results of a study using optical coherence tomography (OCT). The new coronary imaging technology provides resolution 10 times greater than intravascular ultrasound, to examine highly...

Five dialysis deaths prompt Baxter & FDA action. (Breaking News).
September 30, 2002... SEPT. 12, 2002 -- The FDA today announced that Baxter Healthcare Corp has notified dialysis centers that certain blood tubing used with Baxter's Meridian dialysis machines may possibly be linked to five patient deaths and two injuries. These...

FDA to consolidate review responsibilities for new pharmaceutical products. (Breaking News).
September 30, 2002... SEPT. 6, 2002 -- Dr. Lester M. Crawford, FDA's Deputy Commissioner, today announced the consolidation of FDA's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation & Research (CDER). This work is...

What are warning letters? Companies should understand the importance of this "early-warning" message from FDA. (FDA Guidance).
September 30, 2002... US Food & Drug Administration Washington DC A Warning Letter is a written communication from FDA notifying a responsible individual, firm, or facility, that the agency considers one or more products, practices, processes, or other...

Neurosurgeons reveal alarming national statistics on medical liability crisis. (Market Research Studies).
September 30, 2002... American Association of Neurological Surgeons Rolling Meadows IL A new national analysis released Sept. 25, 2002, and conducted by the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS),...

DHHS releases final amendments to HIPAA privacy rule: major changes to patient privacy analyzed. (Market Research Studies).
September 30, 2002... The US Dept of Health & Human Services (HHS) has released final changes to the privacy regulations issued under the Health Insurance Portability & Accountability Act of 1996. The changes will be published in the Federal Register on August 14,...

FDA Deputy Commissioner Presentation at Parenteral Drug Association Conference. (Drug discovery: part 3).
September 30, 2002... Sept. 24, 2002 As you just heard, I first joined the FDA 27 years ago. Now that I am back on my fourth tour with the agency, I find that having that long view is sometimes helpful. It puts things into perspective. For example, I...

California Gov. Davis signs landmark legislation to approve stem cell research. (Breaking News).
September 30, 2002... SEPT. 22, 2002--Joined by actor Christopher Reeve and several of California's leading biotech researchers, Governor Gray Davis today signed land-mark legislation designed to promote stem cell research in California. "Stem cell research is...

FDA effect of user fees on drug approval times, withdrawals & other agency activities: part 1 - report to the chairman committee on health, education, labor & pensions US Senate. (Market Research Studies).
September 30, 2002... Sept. 17, 2002 US General Accounting Office Washington DC Ten years ago, the Congress passed the Prescription Drug User Fee Act (PDUFA) (1) to provide additional resources for the FDA to speed up the process of reviewing...

House passes bill on medical malpractice limits. (Market Research Studies).
September 30, 2002... SEPT. 26, 2002 -- The US House of Representatives passed legislation (217-203 vote), to limit the amount of damages awarded in medical liability cases and supporting patient access to new medical technologies. AdvaMed (Washington DC) has...

Prostate cancer facts. (Market Research Studies).
September 30, 2002... * Prostate cancer is the seventh leading cause of death, a leading cause of death for men, and the second leading cancer cause of death, after lung cancer in the US. The lifetime risk of dying of prostate cancer is about 3%, about 1/10th the...

Cancer meetings.
September 30, 2002... Nov 8-9, 2002 SOPHE 53rd Annual Meeting; "Declaring Our Interdependence: United for Health Education" Philadelphia PA The Society for Public Health Education's annual meeting, cosponsored by CDC and Eta Sigma Gamma, offers over 30...

Russia used medical equipment market. (Market Research Studies).
September 30, 2002... US & Foreign Commercial Service US Department of State Washington DC Russia would appear to have the potential to sustain a healthy market for used medical equipment, particularly for equipment used in the manufacture of...

CDRH to establish new office to regulate in vitro diagnostic devices. (Market Research Studies).
September 30, 2002... SEPT. 12, 2002 -- In the fall of 2002, the US FDA Center for Devices & Radiological Health will establish a new office-level organization, called the Office for in Vitro Diagnostic Device Evaluation & Safety. Dr. Steven Gutman has been selected...

Frequently asked questions about the reprocessing & reuse of single-use devices by third-party & hospital reprocessors: 3 additional questions final guidance for industry & FDA staff. (FDA Guidance).
September 30, 2002... Document issued on: July 9, 2002 This document contains three questions to be added to the 13 questions in Frequently Asked Questions about the Reprocessing & Reuse of Single-Use Devices by Third Party & Hospital Reprocessors; Final...

Frequently asked questions about the reprocessing & reuse of single-use devices by third-party & hospital reprocessors: final guidance for industry & FDA staff. (FDA Guidance).
September 30, 2002... Document issued on July 6, 2001 This document supersedes Frequently-Asked-Questions about the Reprocessing & Reuse of Single-Use Devices by Third Party & Hospital Reprocessors; Final Guidance for Industry & FDA Staff, May 27, 2001. ...

Determining hospital procedures for opened-but-unused, single-use medical devices: request for comments & information; notice. (FDA Guidance).
September 30, 2002... [Federal Register; Aug. 28, 2002; Vol. 67, No. 167; Docket No. 00D-0053; pp. 55269-55270] US Food & Drug Administration Washington DC SUMMARY: The FDA is providing an opportunity for interested persons to submit comments about...

Reuse/sterilization/disinfection/ infectious disease diagnostics.
September 30, 2002... FDA has traditionally not regulated reprocessing of single-use devices, but recently decided that regulation was necessary to assure the safety and efficacy of reprocessed medical devices. The OST Reuse Program is designed to address the issues...