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Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products [[electronic resource]]
| Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1996] |
| Descrizione fisica | 1 electronic resource |
| Soggetto topico | Biologicals - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products |
| Record Nr. | UNINA-9910696917903321 |
| Rockville, MD : , : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1996] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for clinical trial sponsors [[electronic resource] ] : establishment and operation of clinical trial data monitoring committees
| Guidance for clinical trial sponsors [[electronic resource] ] : establishment and operation of clinical trial data monitoring committees |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health, , [2006] |
| Descrizione fisica | ii, 34 pages : digital, PDF file |
| Soggetto topico | Clinical trials - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for clinical trial sponsors |
| Record Nr. | UNINA-9910698844103321 |
Guidance for clinical trial sponsors [[electronic resource] ] : on the establishment and operation of clinical trial data monitoring committees
| Guidance for clinical trial sponsors [[electronic resource] ] : on the establishment and operation of clinical trial data monitoring committees |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health, , [2001] |
| Descrizione fisica | ii, 23 pages : digital, PDF file |
| Soggetto topico | Clinical trials - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for clinical trial sponsors |
| Record Nr. | UNINA-9910698827203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic
| Guidance for industry [[electronic resource] ] : postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Counterterrorism and Emerging Threats : , : Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition, , [2008] |
| Descrizione fisica | 1 online resource (12 pages) |
| Soggetto topico |
Drugs - Side effects - Reporting - Government policy - United States
Dietary supplements - Government policy - United States Influenza |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698954603321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Counterterrorism and Emerging Threats : , : Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : complementary and alternative medicine products and their regulation by the Food and Drug Administration
| Guidance for industry [[electronic resource] ] : complementary and alternative medicine products and their regulation by the Food and Drug Administration |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition, , [2006] |
| Descrizione fisica | 1 online resource (14 pages) |
| Soggetto topico | Alternative medicine - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698870703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components
| Guidance for industry [[electronic resource] ] : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | i, 18 pages : digital, PDF file |
| Soggetto topico | Biological products - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698866303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : FDA export certificates
| Guidance for industry [[electronic resource] ] : FDA export certificates |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Veterinary Medicine : , : Center for Food Safety and Applied Nutrition, , [2005] |
| Descrizione fisica | 6 pages : digital, PDF file |
| Soggetto topico |
Export controls - United States
Biologicals - Government policy - United States Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698836803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Veterinary Medicine : , : Center for Food Safety and Applied Nutrition, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : independent consultants for biotechnology clinical trial protocols
| Guidance for industry [[electronic resource] ] : independent consultants for biotechnology clinical trial protocols |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2004] |
| Descrizione fisica | 1 online resource (i, 4 pages) |
| Soggetto topico |
Consultants - Government policy - United States
Clinical trials - Government policy - United States Medical protocols - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910701998203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, general considerations
| Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, general considerations |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition : , : Center for Veterinary Medicine, , [2003] |
| Descrizione fisica | 20 pages : digital, PDF file |
| Soggetto topico | Electronic filing systems - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698834903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition : , : Center for Veterinary Medicine, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records
| Guidance for industry [[electronic resource] ] : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : , : Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition : , : Center for Veterinary Medicine, , [2002] |
| Descrizione fisica | iii, 12 pages : digital, PDF file |
| Soggetto topico | Electronic records - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698904603321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : , : Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Food Safety and Applied Nutrition : , : Center for Veterinary Medicine, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
