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Titles
- Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry1
- CMC postapproval manufacturing changes for specified biological products to be documented in annual reports1
- Drug products, including biological products, that contain nanomaterials1
- Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff1
- Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers1
- Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps): small entity compliance guide : guidance for industry1
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff1
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- The Division of Biologics Standards1
- [Researcher at FDA's Bureau of Biologics]1