Tag Archives: FDA

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will be hosting a free online discussion on Tuesday, October 25, 2011 that addresses the FDA’s recently released draft guidance documents: Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review (Aug. 15, 2011) Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices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

Biofuel Research

The President’s Council on Jobs and Competitiveness issued an interim report with suggestions to increase job creation and growth in the U.S., as well as plans for encouraging investment in the industry. Of particular interest to the biotech industry, the report offers suggestions for streamlining the FDA approval process. The report also outlines ideas for eliminating capital gains on investments of $25 million or less that are held for at least five years and recommends Read More >

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Is Animal Biotechnology Progressing?

David Edwards

By David Edwards, PhD Director, Animal Biotechnology, BIO One year ago, I was pleased to testify before the U.S. Food and Drug Administration’s (FDA) Veterinary Medicine Advisory Committee (VMAC).  The FDA convened its VMAC meetings on September 19-21, 2010 to discuss an application for a genetically engineered (GE) salmon. Developed by Massachusetts-based AquaBounty Technologies, a BIO member, the AquAdvantage salmon has been genetically engineered to grow year-round.  Conventional salmon only grow in warmer months.  This Read More >

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