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Guidance for clinical investigators, sponsors, and IRBs [[electronic resource] ] : adverse event reporting to IRBs : improving human subject protection
| Guidance for clinical investigators, sponsors, and IRBs [[electronic resource] ] : adverse event reporting to IRBs : improving human subject protection |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
| Descrizione fisica | 1 online resource (6 pages) |
| Soggetto topico |
Clinical trials - Reporting
Human experimentation in medicine Institutional review boards (Medicine) - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for clinical investigators, sponsors, and IRBs |
| Record Nr. | UNINA-9910699066203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages
| Guidance for industry [[electronic resource] ] : standards for securing the drug supply chain : standardized numerical indentification for prescription drug packages |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : , : Center for Drug Evaluation and Research (CDER) : , : Center for Biologics Evaluation and Research (CBER) : , : Office of Regulatory Affairs, , [2009] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico | Drugs - Packaging |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698135903321 |
Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, drug establishment registration and drug listing
| Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, drug establishment registration and drug listing |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
| Descrizione fisica | 13 pages : digital, PDF file |
| Soggetto topico |
Electronic filing systems - Government policy - United States
Drug factories - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698814903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : computerized systems used in clinical investigations
| Guidance for industry [[electronic resource] ] : computerized systems used in clinical investigations |
| Pubbl/distr/stampa | [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2007] |
| Descrizione fisica | 10 pages : digital, PDF file |
| Soggetto topico |
Computer systems - United States
Clinical trials - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698871403321 |
| [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : IRB review of stand-alone HIPAA authorizations under FDA regulations
| Guidance for industry [[electronic resource] ] : IRB review of stand-alone HIPAA authorizations under FDA regulations |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2003] |
| Descrizione fisica | 1 online resource (10 pages) |
| Soggetto topico | Institutional review boards (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-9910699050503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2003] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for institutional review boards (IRBs) [[electronic resource] ] : frequently asked questions, IRB registration
| Guidance for institutional review boards (IRBs) [[electronic resource] ] : frequently asked questions, IRB registration |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] |
| Descrizione fisica | 1 online resource (7 pages) |
| Soggetto topico | Institutional review boards (Medicine) - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for institutional review boards |
| Record Nr. | UNINA-9910699066303321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The open public hearing [[electronic resource] ] : FDA advisory committee meetings
| The open public hearing [[electronic resource] ] : FDA advisory committee meetings |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2004] |
| Descrizione fisica | 1 online resource (7 pages) |
| Soggetto topico | Citizens' advisory committees in science - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Open public hearing |
| Record Nr. | UNINA-9910698905903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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