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Tag Archives: FDA
Unleashing the Promise of Biotechnology to Cure Disease and Save Lives
The other day I came across an article discussing vaccinations and the author mentioned his 15-year-old son asking him: “Dad, what’s polio?” Many of us are old enough to remember a time when polio struck fear and caused suffering for millions. Today, at least in the developed world, polio is something kids have to ask their parents to explain to them. Imagine someday, our grandchildren asking us, “What was cancer?” How great would that be? 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 >
BIO Official Bloggers Program: Focus on Biosimilars
Andrew Williams wrote a second part to his original blog entry on 2011 BIO International Convention preview… This time his focus is on Biosimilars: For BIO attendees interested in learning more about the relatively new pathway for FDA approval of biosimilars, also known as follow-on biologics, there are several sessions devoted to the intricacies of the new law, or how the new legislation is impacting the BIO community. The biosimilar framework was introduced last year Read More >
FDA: A Cornerstone of America’s Economic Future
By Nancy Bradish Myers, JD, President, Alliance for a Stronger FDA For close to 20 years, we have been told that FDA oversees products that represent 25 percent of all consumer spending. This has always been an impressive statistic and often awakened Capitol Hill to the realization that FDA matters in important and unexpected ways. But is that all there is to FDA’s role in the U.S. economy? Fortunately it isn’t. FDA is a regulatory Read More >