Biomedical Market Newsletter articles from January 2001

Biomedical Market Newsletter archives from January 2001

FDA Decides To Maintain Pre-Announced Onsite Inspections : Listing promised or completed corrective actions on Form 483 will continue.
January 31, 2001... The US FDA announced Jan. 4, 2001, that it will make some changes in its standard practices, but retain others, especially regarding onsite facility inspections. The changes are in FDA's standard practices for medical device, drug, food...

FDA Rescinds Letter On Electrophysiology Catheters.
January 31, 2001... December 27, 2000 Dear EP Catheter Manufacturer: On Sept. 1, 2000, we issued a letter that provided you with a streamlined mechanism to revise the indications for use statement for your "standard" cardiac ablation catheter from an...

New Regs Ban Doctor Self-Referrals.
January 31, 2001... WASHINGTON DC-- JAN. 2,2001 -- DHHS has issued new regulations, effective in one year, to ban doctor self-referrals of Medicare patients to many labs, suppliers, home health agencies and other firms with which they have a financial...

DHHS Inspector General Retires.
January 31, 2001... Inspector General June Gibbs Brown retired Jan. 3, 2001. Until a replacement is named, Michael F. Mangano, Principal Deputy Inspector General, will serve as the Acting Inspector General.

Laser Vision Settles FDA Complaint.
January 31, 2001... ST LOUIS USA -- JAN. 12, 2001 -- Laser Vision Centers, Inc. (Nasdaq: LVCI) announced today it reached a settlement with the FDA Center for Devices & Radiological Health on an administrative complaint filed in April 2000 (previously reported by...

Implantable Medical Device & Biocompatible Materials Market.(Statistical Data Included)
January 31, 2001... Business Communications Co Inc Norwalk CT USA Nowhere is the ability to tailor the properties of materials having greater impact than in the $42 bin medical devices market. Advanced coating technology, new knowledge of biocompatibility,...

Hospital e-Procurement Surges By Over $1.6 Bln.(billion)(Statistical Data Included)
January 31, 2001... TORONTO, CANADA- Results from a Millennium Research Group (MRG) survey of US hospital purchasing managers indicate rapid growth in the migration to online procurement in 2000, an industry worth $6.3 bln. While results from the most recent...

Expansion of Medical Device Industry Initiatives.
January 31, 2001... Form 483 policies to continue, FDA says 800 Federal Register/Vol. 66, No. 3 / Jan. 4, 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food & Drug Administration [Docket No. 00N-1678] Expansion of Medical Device Industry Initiatives...

Inclusion of Certain Devices Within the Accredited Persons Program -- Third Party Review of Clinical Data.
January 31, 2001... A Report by the Secretary of DHHS to the US Senate Committee on Labor & Human Resources and to the US House Committee on Commerce Released Dec. 11, 2000 US DHHS FDA Center for Devices & Radiological Health Rockville MD ...

Final HIPAA Privacy Regulations Contain Significant Changes.(Health Insurance Portability & Accountability Act)
January 31, 2001... In a closely watched development, the US Dept of Health & Human Services (DHHS) issued final privacy regulations for electronic health information on Dec. 20, 2000. More than 100 pages in length and accompanied by more than 1,400 pages in...

FDA & Globalization In The 21st Century : FDA Commissioner Addresses National Press Club -- Dec. 12, 2000.
January 31, 2001... I don't believe I need to introduce you to the world of the FDA. It seems we're always in the news. Americans know who we are and what we do. In spring 1999, the group ResearchAmerica queried Americans about the name of the government agency...

FDA Is Attacking Unscrupulous Internet Marketing Practices.
January 31, 2001... The FDA is increasing its enforcement of medical product promotion regulations, especially among companies marketing on the Internet. According to a recent Los Angeles Times article, the FDA issued 15 reprimands in 2000 to medical device...

2nd Annual Medical Industry Directory of Associations-2001[TM] : Approx. 1,2000 medical associations worldwide.(Directory)
January 31, 2001... Publisher's Note Welcome to our all new, 2nd Annual Medical Industry Directory of Associations-2001[TM]. It briefly profiles approximately 1,200 medical associations worldwide. It's also available in a valuable new Microsoft Excel database...