Also: Medical Device Report Oct 5, 2005
According to the Associated Press, plaintiffs argued that the company had led investors to believe the FDA had cleared the product as a drug. The lawsuit was dismissed by a judge in the Southern District of New York on September 30. (Red Herring)
Philip Roth Enters Library of America Oct 5, 2005
Talking with Susan Wood, so formerly of the FDA. A talk with disease-nerd novelist, banjo player, and indie-rock muse Myla GoldbergMyla Goldberg's Wickett's Remedy. (Village Voice)
FDA proposes new feed rules to strengthen ''mad cow'' safeguards Oct 5, 2005
FDA proposes new feed rules to strengthen ''mad cow'' safeguards ... FDA proposes new feed rules to strengthen ''mad cow'' safeguards By FDA/Consumer Union/Public Citizen Oct 4, 2005, 20:18 ... The U.S. Food and Drug Administrations (FDA) proposed regulations governing animal feed critical to preventing the spread of bovine spongiform encephalopathy (BSE) are still too weak to protect consumers. (Food Consumer)
Cytyc Corporation Appoints David Harding to Head International Operations Oct 5, 2005
Risks and uncertainties include, among others, dependence on key personnel, customers and proprietary technology, uncertainty of product development efforts and product acceptance, management of growth and product diversification, entry into new market segments, risks associated with litigation, the effective integration of acquired businesses and technologies, competition and competitive pricing pressures, risks associated with the FDA regulatory approval processes and healthcare reimbursement... (Yahoo Finance -- Scientific & Technical Instr.)
[external] Abbott Labs gets additional FDA approval for Humira Oct 5, 2005
Abbott Labs gets additional FDA approval for Humira - Pharmaceuticals - Medical Products - Health-Care - Company Announcements. E-mail. (Yahoo Finance -- Major Drugs)
FDA Recalls 2 Pre-Cut Dole Salads Oct 5, 2005
Paul area happened two weeks ago -- hospitalizing three of 12 people who became sick -- the FDA said the products were sold nationwide. Eleven of the 12 bought the salads at Rainbow Foods grocery stores in Minnesota. (MEDLINEplus)
Discovery of Ulcer's Germ Etiology Wins Medicine Nobel Oct 5, 2005
As a result of their work, treatment of gastric ulcers now includes routine testing for H. pylori followed by one of the following FDA-approved triple therapy regimens ... Note, although not FDA approved, amoxicillin has been substituted for tetracycline for patients for whom tetracycline is not recommended. (MedPage Today)
Genentech Gang Fights Back Oct 5, 2005
10/3/2005 4:29 PM EDTThe FDA seeks more time to review a safety program for the blood cancer drug ... 9/26/2005 6:12 PM EDTAndrew von Eschenbach faces a tough task as acting chief of the FDA.. (TheStreet.com)
FDA Wants Clarity From Valeant Oct 5, 2005
The FDA is seeking "additional clarification on specific issues previously addressed by Valeant," the company said. "Valeant plans to meet with the FDA, promptly as they have requested, to discuss and resolve these matters." ... Valeant's stock slipped as the company declined to identify the conditions set by the FDA in order for the agency to approve the drug, Zelapar. (TheStreet.com)
More by Leon Jaroff Oct 5, 2005
Even as the FDA bans the herb, other potentially dangerous supplements are taking its place Tuesday, Feb. 10, 2004 ... The FDA needs new authority to evaluate the weight-loss supplement Wednesday, Mar ... The FDA and the dietary-supplements industry battle over the active ingredient in hundreds of popular diet aids Wednesday, Aug. 21, 2002. (Time.com)
Lumenis Announces Sale of 1000th Selecta(R) SLT Laser Worldwide Oct 5, 2005
The use of SLT has increased rapidly, since Lumens' family of Selecta laser systems gained FDA clearance in 2001. This new therapy has demonstrated to clinicians the ability to reduce the need for on-going and repeated medication or therapy, which directly addresses patient compliance concerns. (Yahoo Finance -- Medical Equipment & Supplies)
FDA seeks to eliminate some cattle parts from feed Oct 5, 2005
FDA proposal seeks to reduce mad cow risks - Mad Cow in the U.S. - MSNBC.com ... FDA proposal seeks to reduce mad cow risks ... The new proposal from the Food and Drug Administration will make an already small risk even smaller, acting FDA Commissioner Andrew von Eschenbach said. (MSNBC -- Business)
Dole Prepackaged Salads Linked To E. Coli Outbreak Oct 5, 2005
WRAL.com - Health Team - FDA: Some Prepackaged Salads Linked To E. Coli ... FDA: Some Prepackaged Salads Linked To E. Coli. (WRAL.com, NC)
Classified Ads: October 5, 2005 Oct 5, 2005
HEALTHY VOLUNTEERS 18-45 years of age are being sought for a study investigating potential drug interactions of commonly used drugs that are FDA approved (IRBMED# 2004-0076). Participants must not regularly take medications. (Michigan Daily, MI)
Her Body: How to Boost a Woman's Sex Drive Oct 5, 2005
APThe FDA has put off approval of Procter & Gamble's first female testosterone patch, Intrinsa, until more studies are completed ... Intrinsas hearings were also held right after the Vioxx scandal broke, and that made everyone in the FDA hearing room extremely sensitive to potential risks ... FDA officials were also concerned that testosterone would become the female Viagra, a quick fix for every sex complaint. (Washington Post - Newsweek)
High court takes up physician-assisted suicide Oct 5, 2005
"He is not the FDA [Food and Drug Administration], he is the DEA [Drug Enforcement Administration], and his law enforcement role doesn't allow him to regulate medicine," Stutsman says. Supporters of Ashcroft's approach say such efforts are important to prevent opening a Pandora's box of end-of-life issues. (Christian Science Monitor)
To The Point Oct 5, 2005
Tyco () got an FDA warning regarding production problems with its FlexTra tubes ... Mylan Laboratories () got FDA approval for a generic version of Pfizer's () blood-pressure drug Norvasc; the drug has $2 ... Valeant Pharmaceuticals () said the FDA was set to approve its drug Zelapar to treat Parkinson's disease, but the firm must clarify some issues. (Investors Business Daily)
ABC 7 Medical: Sleep Apnea Oct 5, 2005
Kathy Fowler on set: THE FDA HAS ONLY APPROVED MIRTAZAPINE FOR TREATING DEPRESSION. LARGER STUDIES ARE NEEDED BEFORE THE FDA APPROVES THE DRUG AS A TREATMENT FOR SLEEP APNEA.. Copyright 2005 WJLA-TV All rights reserved. (ABC 7 News, DC - Health)
FDA warns certain Dole prepackaged salads connected to E. coli outbreak Oct 5, 2005
But salads carrying the same production codes have been distributed nationwide, prompting the national warning, the FDA said ... The last reported case connected to the outbreak was reported Sept. 19, the FDA said ... "Given the severity of this illness, FDA believes an urgent warning to consumers is needed. FDA is working closely with the U.S. Centers for Disease Control and Prevention and our state partners to further identify the source of the problem and its scope," said Dr. Robert Brackett,... (Canada.com -- Health)
