FDA Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the
Title:
FDA Guidance for Industry
For the Submission of
Chemistry, Manufacturing and Controls and
Establishment Description Information for
Human Blood and Blood Components
Intended for Transfusion or for
Further Manufacture
and
For the Completion of the
Origin/Publisher:
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/ucm080803.pdf
Document Type:
Guidance for Industry
Content:
This guidance is a list of what a new applicant should submit in support of an application to become a U.S. licensed manufacturer of human blood and blood components.