FDA Guidance for Industry Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
Titel:
FDA Guidance for Industry
Efficacy Studies to Support Marketing
of Fibrin Sealant Products
Manufactured for Commercial Use
Internet:
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080795.pdf
Dokumentenart:
Guidance for Industry
Inhalt:
FDA position bzgl der nötigen Daten zur Unterstützung der Lizensierung von kommerziellen Fibrinprodukten