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Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), Center for Devices and Radiological Health (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2006]
Subjects:
Outcome assessment (Medical care) > United States.
Medical instruments and apparatus > Labeling > Government policy > United States.
Drugs > Labeling > Government policy > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS113413
Description
Item Description:Title from PDF title page (viewed on June 3, 2009).
"Draft guidance".
"Clinical/medical".
"February 2006".
Electronic resource.
Physical Description:ii, 32 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 6/3/09: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071975.pdf ; current access is available via PURL.