Category Archives: Uncategorized

Towards a More Intramural Approach to Biomarker Development

A recent article by Shashi Amur and FDA colleagues on the future of biomarker development (Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization — http://onlinelibrary.wiley.com/doi/10.1002/cpt.136/abstract) provides a solid foundation for ongoing development and review … Continue reading

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Whither Off-Label?

By Peter J. Pitts The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, … Continue reading

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The FDA’s Quality Revolution

By Peter J. Pitts Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.” So said, CDER Director … Continue reading

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The Globetrotting Regulator

By Peter J. Pitts I am putting in a lot of miles on behalf of international regulatory fraternity. Over the last few months I’ve visited Egypt, Indonesia, Vietnam, Taiwan, Mexico, and Brazil, where I’ve had privilege to meet with regulatory … Continue reading

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Disruptive Innovation in Health Care

Disruptive innovation, creating new markets and displacing the old, is currently in the midst of a “big bang.” Technology is serving as the catalyst and helping to develop new breakthroughs, which in turn are spurring on further developments.  Hardware, wearable … Continue reading

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Join Us in Paris for DIA’s Flagship European Offerings

Who doesn’t love April in Paris? Join us as, for the first time ever, DIA’s EuroMeeting and Clinical Forum will run in parallel, from April 13-15 in Paris, France. 2015 marks 50 years since the first European pharmaceutical legislation and … Continue reading

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Peggy Hamburg: FDA’s 21st Century Commissioner

By Peter J. Pitts The FDA is not a monolithic entity. The agency is comprised of over 11,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and … Continue reading

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Are All Men Created “Equivalent”?

By Peter J Pitts Bioequivalence is going mainstream. Ever since the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded in April of 2010 (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index (NTI) … Continue reading

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My Regulatory Grand Tour

By Peter J. Pitts Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Over the past few months I’ve visited with government health officials in China, the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, … Continue reading

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The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times

TIRS Editor-in-Chief Stephen Spielberg recently recorded a podcast with Joseph DiMasi and Kenneth Getz, both from the Tufts Center for the Study of Drug Development. The conversation focused on their paper, published in TIRS, entitle “The Impact of Collaborative and Risk-Sharing Innovation … Continue reading

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