Tag Archives: FDA

Let’s Get PDUFA V Approved, Fast

Marc Boutin

By Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council At this time of the year, it can be helpful to reflect on the past to guide us in the future. I was recently reading an editorial about the National Health Council (NHC) printed in January 1957 – 37 years after the organization’s creation. It spoke about the need for action with “an unprecedented degree of cooperation among health agencies and Read More >

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2012: A Critical Year for Biotechnology

Capitol

In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce uncertainty; and reinforce the position of the industry as a major contributor resolving society’s most pressing needs. Policies to encourage investment in innovation and to speed discovery to scientific breakthroughs simply must be the priority in 2012. The industry relies on a policy and regulatory environment that encourages innovation for much needed treatments and cures for some of the most Read More >

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The Ethics of Global Clinical Trials

Dr. Russell Medford

By Dr. Russell Medford, Salutria Pharmaceuticals Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards Read More >

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CHI Offering Free Webinar on FDA Draft Guidances

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The California Healthcare Institute will be hosting a free online discussion on Tuesday, October 25, 2011 that addresses the FDA’s recently released draft guidance documents: Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review (Aug. 15, 2011) Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices (Aug. 15, 2011) Date: October Read More >

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Medical Innovation at Risk

Scientists

The National Venture Capital Association’s MedIC Coalition recently released a report showing U.S. venture capitalists are decreasing their investments in biopharmaceutical and medical device companies, reducing their concentration in prevalent disease areas and shifting investments towards Europe and Asia. The report, Vital Signs: The Threat to Investment in U.S. Medical Innovation and the Imperative of FDA Reform, strongly indicates that America’s medical innovation economy is in grave danger of losing its primary source of funding, Read More >

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