Cell-Based Combos Should Go Through CBER For Non-Wound Uses – PhRMA
Executive Summary
Cell-based combination therapies should be reviewed by the Center for Biologics Evaluation & Research for indications other than wound healing, Pharmaceutical Research & Manufacturers of America Biologics & Biotechnology/Preclinical Affairs Research Director Sara Radcliffe said June 24
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Combination Rx/Device Products Should Have One FDA Filing, Wyeth Says
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FDA combination product hearing
FDA will hold a public hearing Nov. 25 to discuss the assignment, premarket review and postmarket regulation of combination products. The meeting will be at the DoubleTree Hotel in Rockville, Md. Event will have broader scope than June 24 hearing, which addressed jurisdiction for wound healing products with live cellular components (1"The Pink Sheet" July 1, p. 15)...