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Tag Archives: Food and Drug Administration
The Ethics of Global Clinical Trials
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 >
Is Animal Biotechnology Progressing?
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 >
FDA: How can we improve it?
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 >
A Center for Advancing Translational Science can spur new therapies
Sometimes, spurring the development of new drugs and therapies can be like trying to a cross shark-infested water without a bridge, Dr. Francis Collins, director of NIH, said during his keynote at the Translational Research Forum during the 2011 BIO International Convention. However, during a time of unprecedented scientific advances, but increasingly limited resources, the public and private sectors must learn to combine their respective efforts to relieve human suffering. Dr. Collins gave a rapid Read More >
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Tags: 2011 BIO International Convention, American Clean Energy and Security Act, BIO International Convention, Cures Acceleration Network, FDA, Food and Drug Administration, National Center for Advancing Translational Science, National Institute of Health, NIH, Phase Zero, translational research
Tags: 2011 BIO International Convention, American Clean Energy and Security Act, BIO International Convention, Cures Acceleration Network, FDA, Food and Drug Administration, National Center for Advancing Translational Science, National Institute of Health, NIH, Phase Zero, translational research
If Biotech Builds…Will Financers Come?
Angie Drakulich from PharmaTech Talk writes: In many countries, it’s easy to get the health minister to understand the value of introducing a vaccine and related healthcare training and therapies to his or her population. It’s another thing to get the finance minister to buy into the effort. But healthcare education and training have made and continue to make great inroads into this area. Angie is part of our BIO Official Blog Program. Keep an Read More >
