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  • FDA Scientists Allege Coercion In Medical Device Approval Process

    All I can say here is that this goes back to a earlier post: The 2 New Hot Words in Healthcare: Algorithms and Whistleblowers In this case we have a bit of both, algorithms created by the scientists, but a requested change by the clinical side of the table?  Sounds a bit like the algorithms run...
    Posted to The Medical Quack .... by Barbara Duck on 11-19-2008
    Filed under: Medically Related, Technology, drugs, healthcare, Medical Devices, Prescriptions, FDA, Medications, Whistle Blower, Data, Data Base, Algorithms
  • Leading Medical Groups Advise Against Avandia – FDA to Research – Education Needed

    I will once more mention a potential change of paradigms here with educating the public.   Each patient who took the drug is unique.  Do we have any information on other drugs they were taking at the same time?  Groups will continue to advise against the use until the full facts are known...
    Posted to The Medical Quack .... by Barbara Duck on 10-31-2008
    Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, healthcare, Pharma, PHR, FDA, Marketing, paradigms, personal heatlh records
  • In Two Days, Four New Drugs Stall at FDA

    Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “ There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these days .”  Below are the 4 drugs.  No doubt the...
    Posted to The Medical Quack .... by Barbara Duck on 10-22-2008
    Filed under: Medically Related, Pharma/FDA News, drugs, Pharma, FDA, Ranbaxy, Medications, Drug Safety
  • FDA will open inspection office in China this year

    Some of the duties will be outsourced, but under the control of a local office, and portions of this provision will need an act of Congress, so I might guess now’s the time, or after the election maybe to tackle this issue.  I would also like to see labels on every product stating the city, origin...
    Posted to The Medical Quack .... by Barbara Duck on 10-16-2008
    Filed under: Medically Related, Pharma/FDA News, My Commentaries, drugs, FDA, China, Outsourcing, Food products, Congress Pharma
  • Amgen Sales Rep Can Pursue Wrongful Firing Suit

    Whistle blowers today seem to be playing a role in the move towards transparency in more ways than one, not to mention the bounty that could be there if a case goes to court and wrongdoing is found to be the case.  BD A New Jersey arbitrator ruled that a former Amgen sales rep can proceed with a...
    Posted to The Medical Quack .... by Barbara Duck on 10-16-2008
    Filed under: Pharma/FDA News, Other Items of Interest, drugs, Pharma, FDA, Marketing, Amgen, Whistle Blower
  • Medco To Begin Working with the FDA – Pharmacogenomics Reporting

    This article states part of the reporting system will include information on the willingness of a doctor to use genetic testing, well first of all we need to help the doctors to bring this full circle with the integration into the clinical side of this, as I have spoken to many MDs and they are aware...
    Posted to The Medical Quack .... by Barbara Duck on 10-06-2008
    Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Education, FDA, Pharmaceuticals, Pharmacogenomics, DNA Testing
  • FDA: Tiny Bit of Melamine OK in Most Foods But we Still need better labeling and shipping documentation

    We still need more labeling and the ability for consumers to identify products when recalls are sent out.  Look a the Heparin recall that failed, and that was a drug. In a recent post I had some suggestions that can be read here, including disallowing “blind” shipments so it’s not a rat race t find...
    Posted to The Medical Quack .... by Barbara Duck on 10-03-2008
    Filed under: Medically Related, Pharma/FDA News, drugs, FDA, tainted milk, Melamine, Commerce, Transportation Shipping and Receiving, Food products
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