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This blog discusses FDA policy from the perspective of a former FDA employee (17 years, 3 days). I am currently a Regulatory Compliance Consultant in Tacoma, WA

Owner: carl1Anderson

Listed in: Health

Language: English

Tags: FDA, GCP, Clinical Trials, Medical Devices, Research Ethics

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Latest Blog Posts for Carl's blog on FDA stuff

  • Mountains Beyond Mountains: The Tragedy in Haiti
    on Jan 15, 2010
    Given the enormity of the tragedy in Haiti it is difficult for me to write about FDA guidance documents and regulatory compliance. Instead, I am going to ask you to help with the relief efforts. When natural disasters strike it is often difficult to...
  • Analysis of Recent FDA Warning Letters to IRBs
    on Jan 12, 2010
    A clear pattern is emerging from the recent spate of IRB Warning Letters written by FDA. It appears that IRB registration is working. The Food & Drug Administration is learning just who is approving research in the U.S. The addition to the FDA IR...
  • The Blog Cleans Up Its Act
    on Jan 7, 2010
    Welcome to Carl’s Blog on GxP Stuff. I’ve changed the name from “Carl’s Blog on FDA Stuff” to reflect my evolving interest in focusing on a number of issues and not being “FDA-centric.” There many other regul...
  • The Global Drug Supply Chain
    on Jan 5, 2010
    Just before the new year I paid WordPress a nominal fee to remove ads from The Blog. As I said in an early post (The Blog Reveals All) I do not receive anything from anyone for what I publish in the Blog. However, that doesn’t mean that there i...
  • FDA Reports Scam Using Fake FDA Employees
    on Dec 30, 2009
    I’ve seldom heard of impersonating an FDA official. Evidently its happening. Here is the FDA press release: FDA Warns Public of Continued Extortion Scam by FDA Impersonators http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195814.h...
  • FDA & JAMA Report Problems with Device Data
    on Dec 30, 2009
    The NY Times reported today that a study conducted by FDA and a different study published in the Journal of the American Medical Association (JAMA) have both found problems regarding the quality of the data used to approve cardiovascular medical devi...
  • Scam “clinical trial” targets the hard of hearing
    on Dec 30, 2009
    It was enough to make my blood boil. A family member who has hearing problems passed me an announcement for a “Field Trial Notification” that contained wording that made it sound like a legitimate clinical trial. Things like, “You h...
  • NIDPOE: An FDA Warning Letter on Steroids
    on Dec 14, 2009
    It doesn’t happen very often but for the fourth time this year FDA has issued a NIDPOE letter, Notice of Intitiation of Disqualification Proceedings and Providing Opportunity to Explain. This is only for the most serious breaches of FDA regulat...
  • Another IRB, Another FDA Warning Letter
    on Dec 11, 2009
    FDA is keeping up its scrutiny of Institutional Review Boards with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own IRB and dispense with the formalities, and expense...
  • FDA Hits ICON with Warning Letter for J & J Studies
    on Dec 8, 2009
    FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document list...
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