Research Catalog

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

Title
Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical product development to support labeling claims.
Publication
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]

Available Online

http://purl.access.gpo.gov/GPO/LPS113413

Details

Additional 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.)
Description
ii, 32 p. : digital, PDF file.
Alternative Title
Patient-reported outcome measures, use in medical product development to support labeling claims
Subject
  • Outcome assessment (Medical care) > United States
  • Medical instruments and apparatus > Labeling > Government policy > United States
  • Drugs > Labeling > Government policy > United States
Note
  • Title from PDF title page (viewed on June 3, 2009).
  • "Draft guidance".
  • "Clinical/medical".
  • "February 2006".
System Details (note)
  • 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.
Call Number
GPO Internet HE 20.4702:P 27
OCLC
369319736
Title
Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical product development to support labeling claims.
Imprint
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]
System Details
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.
Connect to:
http://purl.access.gpo.gov/GPO/LPS113413
Added Author
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Center for Devices and Radiological Health (U.S.)
Gpo Item No.
0499-T (online)
Sudoc No.
HE 20.4702:P 27
Research Call Number
GPO Internet HE 20.4702:P 27
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