10 janvier, 2008 23:13
Latest Public Citizen Publications
Your search returned 699 matches
First 10 records
Comments on FDA's Draft Guidance for Industry - Drug-Induced Liver Injury:
Premarketing Clinical Evaluation (HRG Publication #1833)
The FDA's guidance document confirms the agency's continued reluctance to seriously and publicly engage in post-mortem analyses of the growing number of mistakes the FDA has made concerning failed decision-making about either the approval of known hepatotoxic drugs or the dangerously delayed removal of ones showing hepatotoxicity shortly after approval.
[Created on: 12/28/2007]
Comments on the Draft Report on the U.S. System of Oversight of Genetic Testing
(HRG Publication #1832)
The seriousness of mistaken results in genetic testing is so grave that oversight cannot be entrusted to self-interested parties or voluntary efforts by lackluster federal agencies.
[Created on: 12/26/2007]
Letter to the FDA urging against approval of cardiac device REPEL-CV (HRG
Publication #1831)
Public Citizen urges the Food and Drug Administration (FDA) to deny approval to SyntheMed’s REPEL-CV, a device to reduce cardiac adhesions (abnormal scar tissue formation in which surfaces normally separate adhere to each other) from surgery, because the device has not demonstrated a "reasonable assurance that the device is safe and effective," the standard necessary for approval under the law.
[Created on: 12/21/2007]
Santa’s Sweatshop: Made in D.C. With Bad Trade Policy
New analysis of four decades of data on toy imports, production jobs and wages, toy firm profits, CEO pay and toy recalls. The analysis illustrates how the surge in recalls has coincided with the wholesale relocation of toy production offshore as U.S. toy firms have employed a long-term corporate strategy of seeking ever-cheaper wages and raw materials offshore while avoiding oversight and legal liability.
[Created on: 12/19/2007]
Presentation before the Institute of Medicine Committee on Conflict of Interest in
Medical Research, Education, and Practice (HRG Publication #1830)
Disclosure is no substitute for prevention of conflicts when this is feasible and legal. Financial conflicts are of particular concern and merit specific attention. This committee could play a helpful role in delineating how future research should be conducted.
[Created on: 12/14/2007]
Testimony on the public health dangers of making lovastatin (MEVACOR) available
over-the-counter (HRG Publication #1829)
We strongly oppose the switch of lovastatin or any other statin to OTC status. With each look at the latest evidence, the case against such a switch becomes clearer.
[Created on: 12/13/2007]
A Self-Inflicted "Crisis": New York's Medical Malpractice Insurance Troubles Caused
by Flawed State Rating Setting and Raid on Rainy Day Fund
Shortsighted policy decisions by New York’s government in the 1990s are responsible for the purported medical malpractice "crisis" in the state, a report released today by Public Citizen, New York Public Interest Research Group (NYPIRG) and the Center for Medical Consumers concludes.
[Created on: 11/29/2007]
Testimony of Sidney M. Wolfe M.D. on Behind-the-Counter Availability of Certain
Drugs (HRG Publication #1828)
Dr. Wolfe testifies about the benefits and risks of approving availability of certain drugs behind-the-counter.
[Created on: 11/14/2007]
Comments before an FDA advisory committee on the availability of over-the-counter pediatric cough and cold formulations (HRG Publication #1827)
All dosage forms such as droppers or syringes intended for children should be removed from the market; all remaining products should be clearly labeled to say that the products have not been shown to work in children and may be dangerous; and the definition of "children" should be those up to 12 years of age.
[Created on: 10/19/2007]
Letter to the FDA urging an investigation of Medtronic defibrillator recall (HRG
Publication #1826)
The congratulatory comments by both the FDA and Medtronic have covered up the FDA’s failure to stop Medtronic’s outrageous and irresponsible Medtronic direct-to-consumer ad campaign.
[Created on: 10/16/2007]
|
|
