Biomedical Market Newsletter articles from January 2007

Biomedical Market Newsletter archives from January 2007

Miami hospital paid $15.4 Mln to resolve fraud case for alleged kickbacks & medically unnecessary treatments: Fraud & Abuse Alleged.(News & Analysis)
January 1, 2007... On Nov 30 2006, the US Justice Dept announced that Larkin Community Hospital in Miami FL, and its current and former owners, Dr. Jack Michel, Dr. James Desnick, Morris Esformes and Philip Esformes, have paid $15.4 million to settle federal and...

CMS announces accreditation organizations for suppliers of durable medical equipment, prosthetics, orthotics & supplies.(News & Analysis)
January 1, 2007... On Dec 06 2006, the US Centers for Medicare & Medicaid Services (CMS) announced the names of 11 national accreditation organizations that will accredit suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) as...

FDA agreement for shipment of medical devices for sterilization made.(News & Analysis)(Brief article)
January 1, 2007... The US Food & Drug Administration has set a Jan 16 2007 deadline for public comments on its Agreement for Shipment of Devices for Sterilization. Under Sections 501(c) and 502(a) of the Federal Food, Drug & Cosmetic Act, (21 U.S.C. 351(c)...

Large, phase 3 trial of cardiovascular therapy suspended.(News & Analysis)
January 1, 2007... In early Dec 2006, the FDA announced that drug manufacturer Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A). The reason is an increased rate of mortality...

Medicare releases new hospital requirements.(News & Analysis)
January 1, 2007... The US Centers for Medicare & Medicaid Services (CMS) has released a final rule that revises requirements in the hospital conditions of participation (CoPs) for: completion of history and physical examinations, authentication of verbal orders,...

Human tissue intended for transplantation; FDA invites comments on info collection requirements.(News & Analysis)
January 1, 2007... The FDA is inviting public comments on its info collection requirements, with a Feb 02 2007 deadline, on human tissue for transplantation. There are currently approx 190 tissue establishments in the US, of which 105 are conventional tissue...

FDA proposes labeling changes to OTC pain relievers.(News & Analysis)
January 1, 2007... On Dec 20 2006, the US FDA proposed to amend the labeling regulations on OTC Internal Analgesic, Antipyretic & Antirheumatic drug products, to include important safety information regarding the potential for stomach bleeding and liver damage,...

FDA proposes rules overhaul to expand availability of experimental drugs.(News & Analysis)
January 1, 2007... The US Food & Drug Administration on Dec 11 2006, proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and...

Gene therapy clinical trials guidance released.(News & Analysis)
January 1, 2007... On Nov 28 2006, the US FDA released a new guidance document, Guidance for Industry: Gene Therapy Clinical Trials--Observing Subjects for Delayed Adverse Events. The new version provides sponsors of gene therapy studies with recommendations for...

Hemolytic uremic syndrome cases develop from E. coli infections.(News & Analysis)
January 1, 2007... The US Food & Drug Administration on Dec 13 2006, released updated statistics on the E. coli infections linked to a chain of fast food restaurants, showing that 8 people have now reportedly developed hemolytic uremic syndrome, a form of kidney...

FDA warns 5 firms to stop making compounds.(News & Analysis)
January 1, 2007... The US FDA in Dec 2006, has warned 5 firms to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution, rather than responding to the unique medical needs of individual...

Medical industry directory of US associations, organizations & conference organizers-2007[TM]: 7th Annual--Expanded/Updated Edition.
January 1, 2007... --Part 1 --Almost 2,000 associations inside US Researched, Published & Distributed Exclusively By: Biomedical Market Newsletter(R) [c]Copyright 1991-2007 by Biomedical Market Newsletter(R) All rights reserved. Biomedical Market...