Tag Archives: prescription drugs

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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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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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 >

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Biologics & Biosimilars: What is the Science Telling Us?

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Panelists from the varied backgrounds of academia, business and regulation agreed on the highest scientific standards of biosimilar regulation. Each panelist emphasized the need for the most stringent of standards in order to ensure patient safety and efficacy within the emerging biosimilars market. As Brian Liang, Executive Director of the Institute of Health Law Studies at California Western School of Law, summed it up, “the need in biosimilars is to focus on science, not cost. These are Read More >

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