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FDA to Release Final Guidance on Patient-Reported Outcomes

September 15, 2009

FDA to Release Final Guidance on Patient-Reported Outcomes
The FDA plans to unloose a final leadership this fall in continuance the conversion to an act of patient-reported issue data to provide ground of belief of a treatment benefit, Laurie Burke, director of revolve in the mind endpoints and labeling at CDER’s Office of New Drugs, said. There force of will be no major changes in principles or policy direction in the final lead compared with the February 2006 draft guidance — but it will have being much more detailed. Burke declined to specify a date, on the other hand she said the final document has been circulated among officials at CDER, CBER and the Center for Devices and Radiological Health.

Written by Samanta · Filed Under FDA News