The FDA Fails to Follow Its Own Directives and Have an Accelerated Drug Approval Process

Lately, I have been writing about the significant disappointment and anger I feel towards the FDA. Congress has directed the FDA and the FDA’s own regulations require that they have a system for accelerated approval of drugs. Yes, they do have the regulations in place, but they have stopped abiding by their own rules. The [...]

Wall Street Journal – A Burden of Proof for Cancer Drugs

Today’s Wall Street Journal (8-2-07) had a front-page piece entitled Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch. Geeta Anand of the Wall Street Journal wrote it. The story is about Garo Armen and the biotech company, Antigenics Inc., which he founded 12 years ago and at a cost of 300 million [...]

Satraplatin Gets Delayed

Yesterday, I traveled to the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) where they reviewed the application for approval of Satraplatin (see my prior posts). The committee voted 12-0 recommending that the FDA delay the approval until all of the final survival data from the SPARC trial becomes available. [...]

Financial Assistance – Your Life Insurance Policy

When we become end stage, many of our life insurance policies will pay part of our death benefit, tax-free, while we are still alive! If your life insurance policy allows and if you and your family can get comfortable and acknowledge that you are in fact terminal, it might be possible to receive up to [...]

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