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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] ] : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information
| Guidance for industry [[electronic resource] ] : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2007] |
| Descrizione fisica | 1 online resource (10 pages) : charts |
| Soggetto topico |
Polymorphism (Crystallography)
Drug factories - Government policy - United States Drug stability - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699281803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP
| Guidance for industry [[electronic resource] ] : formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP |
| 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 (12 pages) |
| Soggetto topico |
Dispute resolution (Law) - 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-9910699112903321 |
| 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] ] : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
| Guidance for industry [[electronic resource] ] : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] |
| Descrizione fisica | 1 online resource (16 pages) |
| Soggetto topico |
Drug development - Government policy - United States
Drug factories - Government policy - United States Quality assurance - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699126003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : submitting type V drug master files to the Center for Biologics Evaluation and Research
| Guidance for industry [[electronic resource] ] : submitting type V drug master files to the Center for Biologics Evaluation and Research |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | i, 5 pages : digital, PDF file |
| Soggetto topico |
Drug factories - Government policy - United States
Filing systems - United States Biologicals - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698826703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
