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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| COMPLIANCE PROGRAM GUIDANCE MANUAL
Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
7342.007 Addendum |
| Internet: | http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/ucm095253.pdf |
| 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/ |
| Content: | Compliance Program CBER Biologics. General provisions pertaining to the scope and purpose of Part 1271, as well as definitions. |
| Document Type: | Guidance Manual |
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