Biological Product Deviation Reporting (BPDR)
Publications
- Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 10/18/2006
- Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 10/18/2006
- Federal Register: Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule - 11/24/2004
- Federal Register: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000