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

Other author Center for Drug Evaluation and Research (U.S.)
Other author Center for Biologics Evaluation and Research (U.S.)
Other author Center for Devices and Radiological Health (U.S.)
Format Electronic
Publication InfoRockville, 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]
Descriptionii, 32 p. : digital, PDF file
Supplemental Contenthttps://purl.fdlp.gov/GPO/LPS113413
Subjects

Portion of title Patient-reported outcome measures, use in medical product development to support labeling claims
General noteTitle from PDF title page (viewed on June 3, 2009).
General note"Draft guidance".
General note"Clinical/medical".
General note"February 2006".
General noteGPO Cataloging Record Distribution Program (CRDP).
Technical detailsMode 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.
GPO item number0499-T (online)
Govt. docs number HE 20.4702:P 27