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Meta
Tag Archives: FDA
“Approval of Foods from Genetically Modified Animals is Unjustifiably Slow”
The Los Angeles Times reported on concerns within the U.S. animal biotech industry and the chilling effect that will result if the government continues to turn its back on technologies in the pipeline. If the political process doesn’t allow the science-based regulatory process to work, we risk losing out on the benefits of this dynamic industry to other countries that are encouraging research and investment in this area. Rosie Mestel of the Los Angeles Times Read More >
FDA Safety and Innovation Act: A Step Forward for Patients With Rare Diseases
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 >
Biosimilars Ahead, Proceed with Caution
By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong Read More >
Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention
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 >
What Parallel Review Means for Manufacturers
By Stephen Rothenberg, J.D. and Matt Levy, J.D., Numerof & Associates, Inc. (NAI) Currently, the FDA and CMS consider new medical products in series; after FDA approval or clearance, CMS begins consideration of a National Coverage Determination (NCD), if requested by an interested stakeholder. Any party seeking drug approval (e.g., manufacturers, suppliers, providers, medical professional organizations, and Medicare beneficiaries) may initiate a request for an NCD. In addition, CMS may initiate a request for an Read More >
