Tag Archives: PDUFA

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 >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , ,

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 >

Jim's Corner  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , , , , , ,

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 >

Events  |  Leave a comment  |  Email This Post
Tags: , , , , , ,

Let’s Get PDUFA V Approved, Fast

Marc Boutin

By Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council At this time of the year, it can be helpful to reflect on the past to guide us in the future. I was recently reading an editorial about the National Health Council (NHC) printed in January 1957 – 37 years after the organization’s creation. It spoke about the need for action with “an unprecedented degree of cooperation among health agencies and Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , , ,