FDA-Approval Does Not Ensure Safety or Effectiveness of Drugs
When a drug is approved by the U.S. Food and Drug Administration (FDA), it may give some the impression that it is proven to be safe and effective for a certain condition. An investigation by the Milwaukee Journal Sentinel, however, shows that this is not necessarily true. By focusing on new diabetes drugs that have been on the … [Read more...]
Approved Epilepsy Drugs Suicide Warnings
Epilepsy Drugs May Cause Suicidal Thoughts. Federal regulators have approved new suicide warnings for more than two dozen epilepsy drugs. The Food & Drug Administration (FDA) had ordered the label update last December, when it issued a public-health advisory regarding the association between epilepsy drugs and suicidal thoughts … [Read more...]
Botox Rival Dysport Approved by FDA
FDA Issued Black Box Warning For Botox. On the same day it announced a black box warning for Botox and similar drugs, the Food & Drug Administration (FDA) approved another botulinum toxin injection product for the U.S. market. But as we have reported previously, Dysport has been the subject of safety concerns in Australia - … [Read more...]
Company that Approved Fake Medical Trial Sanctioned by FDA
Fake Medical Trial Sanctioned By FDA. U.S. regulators have acted against Coast IRB, a human medical study review firm that approved a clinical trial for a fake medical device that was part of a federal investigation. According to the Food & Drug Administration (FDA), the Colorado Springs, Colo., firm agreed to stop reviewing … [Read more...]
Vasovist Approved for MRA Procedures
Federal Health Regulators have approved a New Gadolinium Contrast Agent. Federal health regulators have approved a new gadolinium contrast agent for use in magnetic resonance angiography, or MRA. The Food & Drug Administration (FDA) chose to approve Epix Pharmaceutical's Vasovist Injection despite the known association between … [Read more...]
Most Prescription Drugs Not Approved for Children
Most Prescription Drugs Not Approved for Children Most parents surveyed believe that the prescription drugs their pediatrician prescribes is safe for their kids. But according to a recent study conducted by doctors and researchers at the University of Michigan, 70% of all available drugs, which includes those used to treat children, … [Read more...]
Bush Signs Consumer Product Safety Bill Into Law
President Bush Signed Product Safety Bill As Approved Into Law. Yesterday, President George W. Bush signed a much-anticipated consumer product safety bill—H.R. 4040 as approved by Congress last month—into law. The legislation reauthorizes the Consumer Product Safety Commission (CPSC) for fiscal years 2010-2014 as well as expands its … [Read more...]
Fairness in Nursing Home Arbitration Act Approved
Nursing Home Arbitration Act Closer To Becoming Law. The House Judiciary Subcommittee on Commercial Law and Administrative Law just approved the Fairness in Nursing Home Arbitration Act of 2008, moving the Act one step closer to becoming law. The Act prohibits the signing of an arbitration agreement as a prerequisite to nursing home … [Read more...]
CPSC Would Get More Money, Power Under Tough Product Safety Bill Approved by Senate
Product Safety Bill Will Increase The Budget And Authority Of CPSC. The Consumer Product Safety Commission (CPSC) will have a bigger budget and more authority if a product safety bill passed by the Senate becomes law. Yesterday, the Senate approved the broadest changes to the nation's product safety system in a generation, responding … [Read more...]
Device to Combat Depression Was Approved Despite Evidence of Its Effectiveness
FDA may soon approve a vagus nerve stimulator made by Cybertronics. On May 24, 2005, newsinferno.com reported that: “Although many experts maintain there is little evidence that the device actually works, the FDA may soon approve a ‘vagus nerve stimulator’ manufactured by Cybertronics, Inc., for the treatment of severe … [Read more...]
