Author Archives: tirsblogeditor

The Changing Landscape and Evolution of Biosimilars

If you search for “Biosimilars” in Google, you will get over 500,000 results – a massive source of information that includes scientific articles, guidelines, positions, product information, stakeholder perspectives and much more on the topic. Biosimilars have already been the … Continue reading

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Full Course of Direct Acting HepC Antiviral Now Available to All Australians

The full twelve-week course of direct acting hepatitis C antiviral oral medicines are now available to all Australians for the subsidized price of a little over A$100.00, or even less for concession card holders. This will allow all patients with … Continue reading

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Australian Update: Changes to TGA and PBS

TGA is undergoing changes in response to a ‘Functional and Efficiency Review’ of the Department of Health – there is now a ‘Regulatory Service Group’ that includes TGA, the Office of Gene Technology Regulator and the Office of Chemical Safety. … Continue reading

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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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Message from DIA 2015 51st Annual Meeting Program Co-Chair Dr. Michael Rosenblatt

Mobilizing medical insight, discovery and invention to help patients is a team effort. Patients and their families expect that we will work collaboratively and use our collective skills to improve health – as efficiently and quickly as possible. No doubt, … 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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In Case You Missed It: April Global Forum Looks at Industry Trends Across the Globe

Have you read the April issue of Global Forum yet? Featuring a new look, and in-depth content from an expanded editorial board, this issue is available open access (no log in required) at http://www.globalforum-online.org. The April issue takes a deep-dive … Continue reading

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