Guidance for industry efficacy studies to support marketing of fibrin sealant products manufactured for commercial use.

Other Authors: Center for Biologics Evaluation and Research (U.S.)
Format: Electronic
Language: English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999]
Physical Description: i, 3 pages : digital, PDF file.
Subjects:
Online Access: https://purl.fdlp.gov/GPO/LPS113530
Item Description: Mode of access: Internet at the FDA web site. Address as of 6/5/09: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080795.pdf ; current access is available via PURL.
Title from PDF title page (viewed on June 5, 2009).
"May 1999".
GPO Cataloging Record Distribution Program (CRDP).
Physical Description: i, 3 pages : digital, PDF file.
Format: Mode of access: Internet at the FDA web site. Address as of 6/5/09: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080795.pdf ; current access is available via PURL.