Category Archives: Podcast

FDA’s Dr. Janet Woodcock Discusses Adaptive Clinical Trials

We are all trying to re-enter the workforce after August.  Here in the Beltway, the Congress is headed back and the traffic congestion returns as students everywhere return to school.  Labor Day Weekend has passed and alas, I have put … Continue reading

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HIV in Africa – A Conversation with Former HHS Secretary Louis Sullivan

Last week the Bush Administration announced that it would be seeking a doubling of the U.S. commitment to fund HIV/AIDS care.  That evening, ABC World News Tonight ran a story on the request and compared before and after photographs of … Continue reading

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FDA and Pharma Images – A Conversation with Patrick Clinton – Pharmaceutical Executive Magazine

As noted in this space many times, the images of the Food and Drug Administration as well as the pharmaceutical industry have been suffering greatly, most certainly in the post-COX-2 era.  The result has been a rash of lawsuits, congressional … Continue reading

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Supplements and Adverse Event Reporting – A Conversation with the Council for Responsible Nutrition

As reported in the past here, the 109th Congress passed S.3546 – The Dietary and Supplement Non-Prescription Drug Consumer Act – legislation that would make it mandatory for manufacturers of dietary supplements and OTC products to report serious adverse events.  … Continue reading

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Approvable Letters – A Conversation with Myself…

I am posting a podcast which, unlike past efforts, is not an interview, but a short discussion on my take on approvable letters.  What makes an approvable letter more likely than an approval letter for investigational products?  While there is … Continue reading

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