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FDASIA: A Step Forward for Patients
Earlier this year, Congress passed and President Obama signed the FDA Safety and Innovation Act (FDASIA) which included a re-authorization of the Prescription Drug User Fee Act (PDUFA). PDUFA provides essential funding to the FDA by authorizing the agency to charge user fees to companies seeking to have products reviewed. Originally enacted in 1992, it must be reauthorized every 5 years. Sara Radcliffe, executive vice president of health at BIO, moderated a panel of experts and advocates Read More >
Delivering on the Promise of Personalized Medicine
As sequencing moves out of the lab and into the clinic, a host of players must get involved to make our collective promises of personalized medicine a reality. CEOs, entrepreneurs, researchers, clinicians, regulators and payers need to work together to take on the next challenges in the implementation of personalized medicine. Some of those challenges include: Cost vs. Benefit: How do we define and benefit from transformational technologies? Form vs. Function: What about the less Read More >
The Future of Biodefense: Will Public-Private Partnerships Continue?
Ten years ago, in the wake of the 2001 anthrax attacks, the U.S. government set out on a bold path to improve the country’s preparedness for bioterrorism by developing and stockpiling new drugs and vaccines to protect Americans from health emergencies. Individuals from both political parties – many who had experienced bioterror first hand – worked together to harness the power of innovative science and tackle this national security threat. The ten year initiative was Read More >
World Diabetes Day: Get the Facts
Today, November 14, is World Diabetes Day and advocacy organizations around the world are focused on raising awareness for prevention and treatment options. How prevalent is diabetes? According to the 2011 National Diabetes Fact Sheet, there are more than 25 million children and adults in the U.S. with diabetes, which includes more than 18 million people who have been diagnosed and an estimated seven million people who have not yet been diagnosed. Nearly 80 million Read More >
It’s World Polio Day – Time to Make History
Oct. 24 is World Polio Day, an opportunity to share a message of extreme importance: The global community must step up now with the resources needed to eradicate this crippling childhood disease once and for all. In all of history, smallpox is the only human disease to be eradicated. It’s time to make global health history a second time by wiping out polio. And that can only happen by reaching every child in every corner Read More >
