Tag Archives: Food and Drug Administration

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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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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FDA: How can we improve it?

Stephen Sherwin MD

By Stephen Sherwin, Former Chairman of BIO As Congress and the President work together to hammer out a new, national economic roadmap, it is important to point out to those working in, and interested in, our industry that we too have recently assembled a roadmap – one designed to fully realize the promise our industry holds for people everywhere. Several weeks ago, at the 2011 BIO International Convention in Washington, DC, BIO unveiled its first ever 5 Read More >

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