FDA Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma- Derived Biological Products, Animal Plasma or Serum-Derived Products
Titel:
FDA Guidance for Industry
For the Submission of Chemistry,
Manufacturing and Controls and
Establishment Description
Information for Human Plasma-
Derived Biological Products, Animal
Plasma or Serum-Derived Products
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/ucm080825.pdf
Dokumentenart:
Guidance for Industry
Inhalt:
Informationen zu den benötigten daten bei einer Lizensierung für Plasmaherstellung