Tag Archives: PDUFA

Empowering You to Make a Difference in Health Care Policy

CMM

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

hamburg

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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Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

bio-session

In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation. Read More >

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