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Antibiotics [[electronic resource] ] : FDA needs to do more to ensure that drug labels contain up-to-date information : report to congressional committees
| Antibiotics [[electronic resource] ] : FDA needs to do more to ensure that drug labels contain up-to-date information : report to congressional committees |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2012] |
| Descrizione fisica | 1 online resource (ii, 35 pages) : illustrations |
| Soggetto topico |
Antibiotics
Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Antibiotics |
| Record Nr. | UNINA-9910701974403321 |
| [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Electronic drug labeling : no consensus on the advantages and disadvantages of its exclusive use : report to congressional committees
| Electronic drug labeling : no consensus on the advantages and disadvantages of its exclusive use : report to congressional committees |
| Pubbl/distr/stampa | [Washington, D.C.] : , : United States Government Accountability Office, , 2013 |
| Descrizione fisica | 1 online resource (ii, 20 pages) |
| Soggetto topico |
Drugs - Labeling - Government policy - United States
Electronic records - Government policy - United States Public health - United States Pharmaceutical industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Electronic drug labeling |
| Record Nr. | UNINA-9910704967503321 |
| [Washington, D.C.] : , : United States Government Accountability Office, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : SPL standard for content of labeling technical Qs & As
| Guidance for industry [[electronic resource] ] : SPL standard for content of labeling technical Qs & As |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2009] |
| Descrizione fisica | 1 online resource (9 pages) |
| Soggetto topico | Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699293703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : bar code label requirements, questions and answers
| Guidance for industry [[electronic resource] ] : bar code label requirements, questions and answers |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2006] |
| Descrizione fisica | ii, 9 pages : digital, PDF file |
| Soggetto topico |
Bar coding - Government policy - United States
Drugs - Labeling - Government policy - United States Biological products - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698802903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : clinical studies section of labeling for human prescription drug and biological products, content and format
| Guidance for industry [[electronic resource] ] : clinical studies section of labeling for human prescription drug and biological products, content and format |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation, , [2006] |
| Descrizione fisica | 1 online resource (22 pages) : illustrations |
| Soggetto topico |
Drugs - Labeling - Government policy - United States
Biologicals - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699063803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : patient-reported outcome measures, use in medical product development to support labeling claims
| Guidance for industry [[electronic resource] ] : patient-reported outcome measures, use in medical product development to support labeling claims |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2006] |
| Descrizione fisica | ii, 32 pages : digital, PDF file |
| Soggetto topico |
Outcome assessment (Medical care) - United States
Medical instruments and apparatus - Labeling - Government policy - United States Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698810703321 |
Guidance for industry [[electronic resource] ] : adverse reactions section of labeling for human prescription drug and biological products, content and format
| Guidance for industry [[electronic resource] ] : adverse reactions section of labeling for human prescription drug and biological products, content and format |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2006] |
| Descrizione fisica | 1 online resource (13 pages) |
| Soggetto topico |
Drugs - Side effects - United States
Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699395803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : clinical lactation studies; study design, data analysis, and recommendations for labeling
| Guidance for industry [[electronic resource] ] : clinical lactation studies; study design, data analysis, and recommendations for labeling |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2005] |
| Descrizione fisica | 1 online resource (19 p) |
| Soggetto topico |
Lactation
Drugs - Labeling - Government policy - United States Biologicals - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699065803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, content of labeling
| Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, content of labeling |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2005] |
| Descrizione fisica | 1 online resource (i, 5 pages) |
| Soggetto topico |
Drugs - Labeling - Government policy - United States
Biologicals - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699111403321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling
| Guidance for industry [[electronic resource] ] : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation : , : Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | 1 online resource (5 pages) |
| Soggetto topico |
Electronic records
Advertising - Drugs - Government policy - United States Drugs - Labeling - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699292803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation : , : Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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