FDA flub tied to heparin scare

Tribune-Review/Pittsburgh Tribune-Review;  February 19, 2008 ;     541 words ......dialysis patients. The FDA does not know the...and is not sure if Changzhou SPL is the source of the...deputy director at FDA's Center for Drug...scheduled for inspection." Changzhou SPL was confused with...said. Therefore, the FDA did not inspect Changzhou SPL ...

FDA Cites Problems at Chinese Plant Making Blood Thinner

The Washington Post;  February 29, 2008 ;     590 words ......made public yesterday, the FDA inspectors also described...stopped production, but the FDA wanted to keep the existing...Kweder, deputy director of the FDA's Office of New Drugs, Center...with Baxter's heparin, and FDA's oversight of its production...their own have skyrocketed, FDA's budget ...

FDA FOREIGN DRUG INSPECTION PROGRAM:DAVID NELSON

Congressional Testimony;  April 29, 2008 ;     700+ words ......of API to Baxter, Changzhou SPL, and both of the...heparin to that plant. FDA inspectors issued...blocks imports from Changzhou SPL until all outstanding...reinspected. While FDA may respond quickly...Inspection Policy FDA acknowledges that...Chinese facility, Changzhou ...

FDA finds faults at China plant that makes heparin ingredient

The Milwaukee Journal Sentinel;  April 22, 2008 ;     532 words ......a warning letter to Changzhou SPL Co., the FDA said an inspection...Laboratories. According to the FDA's findings: - Changzhou SPL "failed to perform...did not believe the FDA warning letter "reflects Changzhou SPL's actual state of compliance...

SEN. GRASSLEY PRESSES FDA FOR MORE INFORMATION ABOUT FOREIGN INSPECTIONS,...

US Fed News Service, Including US State News;  February 28, 2008 ;     700+ words ......access to its own translators, what systems, if any, does FDA have in place to ensure that the Agency is receiving...provided by the inspected facilities? Has or would the FDA consider employing independent contractors to assist with translations during its foreign inspections? In FDA's December 12, 2007 ...

FDA's Inspection Program Under Scrutiny

Biopharm International;  April 1, 2008 ;     700+ words ......poured in, that FDA discovered the inspection...Unfortunately, FDA staffers confused Changzhou SPL's name with a plant...into the record, Changzhou SPL was not visited...adverse events, FDA inspectors swarmed...make the product." FDA inspectors ruled...when they visited ...

FDA URGES TEST OF HEPARIN FOR CONTAMINANTS OFFICIALS FEAR DEATHS AND...

Wisconsin State Journal (Madison, WI);  March 7, 2008 ;     462 words ......in turn owns a Chinese factory - Changzhou SPL - and buys additional raw heparin...bigger heparin problem. Instead, the FDA said that Germany is recalling...the heparin problem is not within Changzhou SPL's or Baxter's manufacturing facilities...

GRASSLEY PRESSES FDA FOR MORE INFORMATION ABOUT FOREIGN INSPECTIONS, DRUG...

Capitol Hill Press Releases;  February 28, 2008 ;     700+ words ......access to its own translators, what systems, if any, does FDA have in place to ensure that the Agency is receiving...provided by the inspected facilities? Has or would the FDA consider employing independent contractors to assist with translations during its foreign inspections? 2. In FDA's December 12, ...

Abolishing the FDA

Freeman;  March 1, 2007 ;     700+ words ...The Food and Drug Administration (FDA) started out as a bulwark against snake...and subservience to the drug industry. The FDA seems indifferent to the many deaths its...come to seriously consider abolishing the FDA. Before 1992 the FDA was no friend of the...

A TIP FROM FDA LED TO SEC'S SUIT AGAINST BIOPURE

The Boston Globe;  October 10, 2005 ;     700+ words ...The FDA dropped the dime. According to a government...and several executives hid from investors the FDA's safety concerns about its products while...effects of the closer cooperation between the FDA and the SEC to police biotechnology companies...

Not good enough: Some feel FDA's easing of off-label rules still falls...

Drug Topics;  January 22, 1996 ;     700+ words ...Some feel FDA's easing of off-label rules still falls short...recently released draft policy guidelines, the FDA would let pharmaceutical manufacturers distribute...failed to attract enthusiastic support. "The FDA's action indicates that it continues to believe...

Not enough warning: GAO report finds FDA's medical device monitoring...

Modern Healthcare;  March 10, 1997 ;     700+ words ...GAO report finds FDA's medical device monitoring lacking The...underreporting of device-related problems to the FDA by user facilities, such as hospitals. In...medical-device law in 1990 to boost field data at the FDA's disposal by making user reporting mandatory...

FDA asks HHS Inspector General to investigate FDA-sponsored clinical...

M2 Presswire;  March 24, 2003 ;     700+ words ...M2 PRESSWIRE-24 March 2003-US FDA: FDA asks HHS Inspector General to investigate FDA-sponsored clinical trial(C)1994-2003 M2 COMMUNICATIONS LTD RDATE:03212003 The Food and Drug Administration (FDA) today announced that it has asked the Inspector General...

One Man's Ode to the FDA; Agency Is Often Criticized, but Employees Sing...

The Washington Post;  July 31, 2006 ;     700+ words ..."FDA Centennial Anthem" won't be mistaken for "The...singing along. The anthem might be true to the FDA's roots in the Progressive Era of Theodore Roosevelt...stanzas of lofty sentiment does it acknowledge FDA setbacks, such as the handling of Vioxx, a drug...

FDA and SEC work to enhance public's protection from false and misleading...

M2 Presswire;  February 6, 2004 ;     656 words ...M2 PRESSWIRE-6 February 2004-US FDA: FDA and SEC work to enhance public's protection from false and misleading...COMMUNICATIONS LTD RDATE:02052004 The Food and Drug Administration (FDA) is announcing new measures designed to improve the manner by which...