Tag Archives: PDUFA

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 Originally enacted in 1992, it must be reauthorized every 5 years.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 >

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Empowering You to Make a Difference in Health Care Policy


Access to medicines. Healthcare reform. Innovation. These issues are critical to the health of Americans — and the Campaign for Modern Medicines is working on them every day. The Campaign for Modern Medicines is a coalition of non-profit organizations, businesses, and individuals from across the country who believe that a vibrant community of empowered advocates can make a real impact on the policy decisions that will improve our health. With the support of our partners, Read More >

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FDA Safety and Innovation Act: A Step Forward for Patients With Rare Diseases

Peter L. Saltonstall

By Peter L. Saltonstall, President and CEO, National Organization for Rare Disorders (NORD) The Food and Drug Administration Safety and Innovation Act (FDASIA) includes the most groundbreaking measures for rare disease patients and their families since the Orphan Drug Act of 1983.  And, just as the rare disease patient community—with NORD as its unifying voice—played a major role in the Orphan Drug Act, NORD and rare disease patients have taken a leadership role in developing Read More >

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Analysis and Impact of PDUFA V


As the House of Representatives voted unanimously to approve legislation to approve the Prescription Drug User Fee Act (PDUFA) V, industry leaders gathered at the 2012 BIO International Convention for a lively discussion on the changes the new legislation, focused on modernizing Food and Drug Administration regulations, will bring to the biotechnology industry. The super session panel discussion was moderated by Steve Usdin, Washington Editor of BioCentury and Co-Host of BioCentury This Week, and included Read More >

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We Are BIO

Jim Greenwood

Here’s what the Biotechnology Industry Organization is doing for you. This year, we challenged you to answer the question – What’s Your BIO? On behalf of the Biotechnology Industry Organization (BIO), I’d like to answer that question to illustrate how we advocate for federal, state and global policies to foster continued biotech breakthroughs, innovation and ingenuity. In addition to producing the BIO International Convention, we educate and engage public policy leaders in Washington, in state Read More >

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