Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner, Part 4

In this, the final installment of a 4-part interview with Dr. David Kessler, we departed from our discussion about the past and the present to talk a bit about the future.  For some time, two developments that have often captured headlines and the public imagination are to do with the development of a regulatory pathway for biosimilars and the promise of personalized medicine.

How close are we to realities in these areas.  Not long ago, the FDA scheduled a public meeting to be held to get public input on a wide range of questions that are in consideration for the development of a biosimilar regulatory pathway.  And one can see from the breadth and depth of the questions, coupled with the FDA's very slow process for guidance development, that clarification in this area may be a while in coming.

And with respect to personalized medicine – the day when we can be tested to determine which medicines might work best for us personally – there has long been promise of more effective treatment.  Does the realization of personalized medicine demand some changes to the way we currently regulate medical products?

I want to thank Dr. Kessler again for taking the time he did with me to film these interviews and for his valuable insights into these and other questions.


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1 Response to Then and Now – An Interview with Dr. David Kessler, Former FDA Commissioner, Part 4

  1. Karl Simpson says:

    Good interview that underlines the significant costs that will need to be met in bringing a biosimilar to market. Also the complex regulatory framework that currently exists in the diagnostic and drug markets and how they meet in personalized medicine.

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