Biomedical Market Newsletter articles from October 2001

Biomedical Market Newsletter archives from October 2001

Agreements Signed By US & UK To Collaborate On Healthcare Quality & Bioterrorism.(Brief Article)
October 26, 2001... On Oct. 11, 2001, the US and United Kingdom agreed to new joint healthcare quality efforts, as well as preparing an effective response against possible acts of bioterrorism. Meeting in Washington DC, DHHS Secretary Tommy G. Thompson and the...

DHHS Releases $50 mln To Fund 94 New Research Grants, Contracts & Projects : To help reduce medical errors & improve patient safety.(Brief Article)
October 26, 2001... OCT. 10,2001 -- WASHINGTON DC -- DHHS Sec. Tommy G. Thompson today announced the release of $50 mln to fund 94 new research grants, contracts and other projects to reduce medical errors and improve patient safety. The initiative represents...

It's Official: Life Expectancy In US Hits New High Of 76.9 Years.(Brief Article)(Statistical Data Included)
October 26, 2001... OCT. 10, 2001 -- ATLANTA GA USA -- Life expectancy for the US population reached a record high of 76.9 years in 2000. In particular, mortality declined for several leading causes of death, according to preliminary figures from a report released...

Organ & Tissue Donation Groups Receive $10 mln DHHS Award To Increase The Number Of Donors.(Brief Article)
October 26, 2001... OCT. 2, 2001 --WASHINGTON DC -- DHHS Sec. Tommy G. Thompson today announced grants expected to total nearly $10 mln over the next three years to 12 organizations, to expand research into strategies that will increase the number of US organ and...

"Push Pack" Emergency Medical Supplies Were Used In NYC Disaster, As Part Of 1st-Ever Use Of National Pharmaceutical Stockpile.(Brief Article)
October 26, 2001... On Sept. 11, 2001, DHHS Sec. Tommy G. Thompson authorized the first emergency use of the National Pharmaceutical Stockpile, drawing on the 2-year-old rapid response program to provide special aid to New York City. The decision resulted in...

Sentinel System Launched To Monitor US Blood Supply On A Daily Basis.(Brief Article)
October 26, 2001... In Aug. 2001, only five weeks prior to the terrorist attack in New York, Pennsylvania and Washington DC, DHHS Secretary Tommy G. Thompson announced that a new "real time" monitoring network was being launched to measure the blood supply in key...

New Global Health Issues Website.(Brief Article)
October 26, 2001... DHHS has launched a new website that addresses the inextricable link between domestic and international health issues. The site: http:// www.globalhealth.gov, provides information on the department's work on global health issues, as well as...

Only 4 Weeks Before Sept. 11 & 2 Months Prior To Anthrax Cases, DHHS Released These Plans To Address Bioterrorism Threat : DHHS INITIATIVE PREPARES FOR POSSIBLE BIOTERRORISM THREAT.
October 26, 2001... August 16, 2001 Overview: While the exact risks are unknown, the use of biological weapons by terrorists potentially could result in life-threatening illness on a large scale. Even a lone terrorist could cause a major disease outbreak in...

FDA Acts To Approve Other Drugs To Treat Anthrax Exposure.
October 26, 2001... Websites are allegedly charging $5-$7 per pill for Cypro, while FDA & consumers fear counterfeits are being shipped OCT. 19, 2001 -- WASHINGTON DC -- Secretary of Health & Human Services Tommy G. Thompson announced on Oct. 17, 2001, in...

FDA Acts to Improve Ability to Monitor Marketed Pharmaceuticals.
October 26, 2001... OCT. 17, 2001--WASHINGTON DC--The FDA's Center for Drug Evaluation & Research (CDER) today awarded contracts that give the FDA access to commercial databases that contain nonpatient-identifiable information on the actual use of marketed...

French Drug Firm Pleads Guilty To Felony For Defrauding The FDA : Sentenced to pay $33 mln in criminal & civil penalties in landmark case.(Roussel Uclaf S.A.)
October 26, 2001... OCT. 19, 2001 -- WASHINGTON DC -- Thomas M. DiBaggio, US Attorney for the District of Maryland, Asst Attorney General Robert D. McCallum, Jr., of the US Dept of Justice's Civil Division, and Bernard A. Schwetz, Acting Commissioner of the US...

American Public Health Association Executive Director Wants Vaccines Available To Public Now : Preventing bioterrorism is better than having to respond afterwards to a disaster, he says.(Mohammad N. Akhter)
October 26, 2001... OCT. 9, 2001 -- WASHINGTON DC -- The Executive Director of the American Public Health Association, Mohammad N. Akhter, MD, MPH, today told a Senate committee that a national group of experts should be formed immediately to study the risks and...

Globalization of Clinical Trials : A Growing Challenge in Protecting Human Subjects.
October 26, 2001... This is the 1st concrete evidence from independent sources of the explosion in overseas clinical trial activities Released Oct. 2001; Excerpted Version Janet Rehnquist Inspector General Washington DC EXECUTIVE SUMMARY ...

Systems To Screen Plasma For HIV & Hepatitis C Approved By FDA : Antigen testing cuts the window period for detection.(nucleic acid test approved)
October 26, 2001... SEPT. 21,2001 -- WASHINGTON DC -- The FDA has licensed the first nucleic acid test (NAT) systems intended for screening of plasma donors. These test systems are expected to further ensure the safety of plasma-derived products by permitting...

President Bush's Videotaped Remarks to the American Society of Anesthesologists.
October 26, 2001... Oct. 14, 2001 Thank you very much. I'm honored to have this opportunity to speak to the American Society of Anesthesiologists. During the past few days, our nation has experienced one of the darkest moments in our history. Yet, even in the...

DHHS Sec. Tommy Thompson Testifies On Bioterrorism.
October 26, 2001... Senate Testimony, Oct. 9, 2001 Before the Senate Appropriations Subcommittee on Labor, Health & Human Services, Education & Related Agencies US Senate Washington DC Thank you for your attention to a subject that has long been an...

FDA CDRH Strategic Plan Released.(regulation of biomedical industry)
October 26, 2001... Oct. 2, 2001 US FDA Washington DC OVERVIEW CDRH must work with a broad spectrum of stakeholders, ranging from consumers to medical professionals, to the industries we regulate. They expect us to manage risks presented by advancing...

FDA CDRH Organization Structure.(Directory)
October 26, 2001... Updated Sept. 28, 2001 TITLE NAME Office of the Center Dir Center Dir David Feigal MD MPH Senior Assoc Dir Lillian J. Gill, Acting Deputy...

Taking Cipro To Protect Against Anthrax May Not Be Such A Great Idea : Epilepsy Foundation Warns It May Cause Seizures in Some People.
October 26, 2001... OCT. 19, 2001 -- WASHINGTON DC -- The Epilepsy Foundation announced today that it's medical advisors have warned that fluoroquinolone antibiotics that include Cipro (ciprofloxacin) -- the first line of defense for anthrax -- can in certain...

Federal Government Asks Vaccine Manufacturers For Urgent Help.(smallpox vaccine manufactures asked to increase production)
October 26, 2001... OCT. 19, 2001--WASHINGTON DC--DHHS officials today asked potential smallpox vaccine manufacturers for their urgent assistance. They have been requested to provide by Oct. 24, 2001, detailed information about their capability to produce millions...

Hong Kong & Asian Websites.
October 26, 2001... * American College of Chest Physicians (Hong Kong & Macau Chapter) An association that promotes the prevention & treatment of diseases of the chest through leadership, education, research, & communication. This is the site of the local...

Terrorism Concerns Hit Medical Congresses: How Bad Is The Damage? New Market Research Study Launched to Find Out.
October 26, 2001... MONTREAL CANADA--OCT. 9, 2001 -- Over 184,000 physicians are being consulted worldwide in an upcoming study that will examine how badly terrorism concerns will impact medical congress attendance in the coming year The study that is now...

Reimportation Of Pharmaceuticals Into The US Is Becoming A Significant Problem : Practice Encourages Entrance of Counterfeit Bulk Drugs.
October 26, 2001... Senate Testimony, Sept. 5, 2001 Statement of William K. Hubbard Sr Associate Commissioner for Policy, Planning & Legislation US Food & Drug Administration Before the Subcommittee on Consumer Affairs, Foreign Commerce & Tourism...

Medical Device Labeling Regulations Released By FDA.
October 26, 2001... Federal Register: Oct. 16, 2001 Vol. 66, No. 200; pgs 52630-52634 [Docket No. 01N-0267] SUMMARY: The Food & Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the...

FDA Announces Reuse Policy Changes : Changes in Enforcement of FDA's Requirements on Reprocessing Single-Use Devices.
October 26, 2001... Sept. 25, 2001 Dear Hospital Administrator & Hospital Risk Mgr: The purpose of this letter is to alert you to a change in FDA's policy on the reuse of single-use devices (SUDs) that will affect all hospital SUD reprocessors....

FDA Announces Important New Grants for Clinical Studies of Safety & Effectiveness of Orphan Products; Applications Are Invited [Excerpts of Federal Register Notice: Aug. 27, 2001; Vol. 66, No, 166; Page 45048-45053].
October 26, 2001... SUMMARY: The FDA is announcing changes to its Orphan Products Development (OPD) grant program for FY 2002. The application receipt dates are Oct 17, 2001 [now passed], and March 5, 2002. Application forms are available from, and completed...

FDA Says It Does Not Intend To Enforce Premarket Requirements For Reprocessing Of Catheters : Deadline is delayed until Feb. 14, 2002.
October 26, 2001... AUG. 16, 2001 -- WASHINGTON DC -- The FDA has notified four reprocessors of single-use ablation catheters that the agency does not intend to enforce premarket requirements for their catheters until Feb. 14, 2002. These reprocessors...

CDC Investigation of Anthrax Released.(Centers for Disease Control and Prevention)
October 26, 2001... Reported by: L Bush, MD, Atlantis; J Malecki, MD, Palm Beach County Health Dept, Palm Beach; S Wiersma, MD, State Epidemiologist, Florida Dept of Health; K Cahill, MD, R Fried, MD; M Grossman, MD, Columbia Presbyterian Medical Ctr; W...

Orthopedic Market: Hip Fracture Patients.(movement to improve hip fracture care)
October 26, 2001... OCT. 12, 2001 -- NEW YORK NY -- "Hip fractures are one of the most common, costly, and devastating injuries suffered by Americans. They are occurring at an epidemic rate, with over 350,000 incidents per year accounting for approximately 30% of...

Anthrax Questions & Answers.
October 26, 2001... Centers for Disease Control & Prevention National Center for Infectious Diseases Division of Bacterial & Mycotic Diseases Atlanta GA What is anthrax? Anthrax is an acute infectious disease caused by the spore-forming bacterium...