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Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013
| Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 30 pages) |
| Collana | S. hrg. |
| Soggetto topico |
Veterinary drugs - Government policy - United States
Drug approval - Government policy - United States User charges - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Animal drug user fee agreements |
| Record Nr. | UNINA-9910702742203321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for FDA staff and industry [[electronic resource] ] : marketed unapproved drugs, compliance policy guide
| Guidance for FDA staff and industry [[electronic resource] ] : marketed unapproved drugs, compliance policy guide |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] |
| Descrizione fisica | 1 online resource (i, 12 pages) |
| Soggetto topico |
Drugs - Marketing - Government policy - United States
Drug approval - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for FDA staff and industry |
| Record Nr. | UNINA-9910699125803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : formal meetings between the FDA and sponsors or applicants
| Guidance for industry [[electronic resource] ] : formal meetings between the FDA and sponsors or applicants |
| 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 (11 pages) |
| Soggetto topico |
Discussion - Government policy - United States
Drug approval - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699364203321 |
| 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] ] : M4, organization of the CTD
| Guidance for industry [[electronic resource] ] : M4, organization of the CTD |
| 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, , [2001] |
| Descrizione fisica | 7 pages : digital, PDF file |
| Soggetto topico | Drug approval - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698951003321 |
| 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, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4S, the CTD, safety
| Guidance for industry [[electronic resource] ] : M4S, the CTD, safety |
| 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, , [2001] |
| Descrizione fisica | ii, 21 pages : digital, PDF file |
| Soggetto topico |
Drug approval - Government policy - United States
Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948603321 |
| 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, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4S, the CTD, safety appendices
| Guidance for industry [[electronic resource] ] : M4S, the CTD, safety appendices |
| 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, , [2001] |
| Descrizione fisica | pages 21-115 : digital, PDF file |
| Soggetto topico |
Drug approval - Government policy - United States
Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948403321 |
| 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, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4Q, the CTD, quality
| Guidance for industry [[electronic resource] ] : M4Q, the CTD, quality |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] |
| Descrizione fisica | 29 pages : digital, PDF file |
| Soggetto topico |
Drugs - Quality control - Government policy - United States
Drug approval - Government policy - United States Clinical trials - Reporting - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698948703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : M4E, the CTD, efficacy
| Guidance for industry [[electronic resource] ] : M4E, the CTD, efficacy |
| 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, , [2001] |
| Descrizione fisica | iii, 58 pages : digital, PDF file |
| Soggetto topico |
Drug approval - Government policy - United States
Clinical trials - Reporting - United States Drugs - Effectiveness - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698950803321 |
| 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, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : format and content for the CMC section of an annual report
| Guidance for industry [[electronic resource] ] : format and content for the CMC section of an annual report |
| Pubbl/distr/stampa | [Rockville, MD] : , : Center for Drug Evaluation and Research, , [1994] |
| Descrizione fisica | 1 electronic resource (10 pages) : forms |
| Soggetto topico |
Drug approval - Government policy - United States
Corporation reports - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696916503321 |
| [Rockville, MD] : , : Center for Drug Evaluation and Research, , [1994] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and FDA staff [[electronic resource] ] : application user fees for combination products
| Guidance for industry and FDA staff [[electronic resource] ] : application user fees for combination products |
| 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, , [2005] |
| Descrizione fisica | 15 pages : digital, PDF file |
| Soggetto topico |
User charges - Government policy - United States
Drug approval - Government policy - United States Chemotherapy, Combination |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698929103321 |
| [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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