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Sentinel: Harnessing the Power of Databases to Evaluate Medical Products
By: Michael D. Nguyen, MD Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the...
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Naming and Biological Products
By: Janet Woodcock, M.D. and Karen Midthun, M.D. To create market competition among biological products and lower costs, the Affordable Care Act created a new approval pathway for products that are...
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CBER’s Laboratory Quality System Management Helps Keep Biological Product...
By: Peter Marks, M.D., Ph.D. Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the Center as the preeminent regulatory organization for biologics. One way...
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FDA’s Science-based Approach to Genome Edited Products
By Robert M. Califf M.D., and Ritu Nalubola, Ph.D. Recent scientific advances now make it possible to more efficiently and precisely alter the genome of plants, animals, and microorganisms to produce...
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This is Not a Test: RMAT Designation Goes Live
By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue...
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