Tag Archives: patients

FDASIA: A Step Forward for Patients

fdasia-panel

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 Originally enacted in 1992, it must be reauthorized every 5 years.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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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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Bringing Hope to Patients

Jim Greenwood

No-one expected Hope Bartley to survive after she was born three months early. Thanks to extraordinary biotech medicine, she did. Alena Galan, age 14, is one of only a few thousand patients with a rare disease called MPS. Thanks to the hard work of leading biotech scientists and the approval of a new treatment, she now has a chance to lead a normal life. Lori Lober experienced the unthinkable when she was diagnosed with Stage Read More >

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From Despair to Hope, a New World of Treatments

Test Tubes

By David Welch, President and Senior Producer, M2 MultiMedia Communications Tonight, Wednesday March 28 at 9:00 EST, a documentary called From Despair to Hope, A New World of Treatments, will be broadcast on WUSA-TV, the CBS affiliate in Washington, D.C.  It is sponsored by the Biotechnology Industry Organization. For me, producing this program was a yet another profound reminder of the contributions of biotechnology companies that are helping millions of patients throughout the world live hopeful Read More >

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