Guidance for industry [[electronic resource] ] : compliance with 21 CFR part 1271.150(c)(1), manufacturing arrangements |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2006] |
Descrizione fisica | i, 3 pages : digital, PDF file |
Soggetto topico |
Human cell culture - Government policy - United States
Tissue engineering - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698847803321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2006] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2005] |
Descrizione fisica | i, 8 pages : digital, PDF file |
Soggetto topico |
Tissue engineering - Side effects - Reporting - United States
Human cell culture - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698843603321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2005] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and staff [[electronic resource] ] : minimal manipulation of structural tissue jurisdictional update |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products : , : Center for Biologics Evaluation and Research, , [2006] |
Descrizione fisica | i, 3 pages : digital, PDF file |
Soggetto topico |
Human cell culture - Government policy - United States
Tissue engineering - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and staff |
Record Nr. | UNINA-9910698854003321 |