FDA Week - 01/11/2019

Gottlieb: New Office Of Drug Evaluation Science Will Change Drug Review

January 08, 2019
FDA is setting up a new Office of Drug Evaluation Science (ODES) that will act as a centralized point of information for various performance metrics and provide more predictable and efficient assessment of safety data, FDA Commissioner Scott Gottlieb announced Tuesday (Jan. 8). He said the new office is part of a broader effort to “change the whole contours” of how FDA reviews drugs by moving towards standardized review methods. Gottlieb said via teleconference at the J.P. Morgan Healthcare Conference...

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