Guidance for industry [[electronic resource] ] : fast track drug development programs, designation, development and application review |
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 | 21 pages : digital, PDF file |
Soggetto topico | Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698808403321 |
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] | ||
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Lo trovi qui: Univ. Federico II | ||
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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] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : street drug alternatives |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2000] |
Descrizione fisica | 1 online resource (4 unnumbered pages) |
Soggetto topico |
Drugs of abuse
Alternative medicine - Government policy - United States Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910699115103321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2000] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : population pharmacokinetics |
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, , [1999] |
Descrizione fisica | 1 online resource (iii, 31 p) |
Soggetto topico |
Population
Pharmacokinetics Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910699246503321 |
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, , [1999] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : manufacturing, processing, or holding active pharmaceutical ingredients |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1998] |
Descrizione fisica | 1 online resource (iii, 53 pages) |
Soggetto topico | Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910699125703321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1998] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and FDA [[electronic resource] ] : current good manufacturing practice 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, , [2004] |
Descrizione fisica | 8 p : digital, PDF file |
Soggetto topico |
Drug development - Government policy - United States
Chemotherapy, Combination - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and FDA |
Record Nr. | UNINA-9910698837603321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2004] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and FDA staff [[electronic resource] ] : early development considerations for innovative 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, , [2006] |
Descrizione fisica | 13 pages : digital, PDF file |
Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Drug development - Government policy - United States Biological products - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and FDA staff |
Record Nr. | UNINA-9910698991403321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2006] | ||
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Lo trovi qui: Univ. Federico II | ||
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Medicaid Pharmaceutical Home Act of 2018 : report together with additional views (to accompany H.R. 5808) (including cost estimate of the Congressional Budget Office) |
Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2018] |
Descrizione fisica | 1 online resource (36 pages) |
Collana | Report / 115th Congress, 2d session, House of Representatives |
Soggetto topico |
Medicaid
Medicare Drugs - Prescribing - United States - Management Opioid abuse - Treatment - United States - Costs Drug development - Government policy - United States Drugs - Generic substitution - Government policy - United States |
Soggetto genere / forma | Legislative materials. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Medicaid Pharmaceutical Home Act of 2018 |
Record Nr. | UNINA-9910709757803321 |
[Washington, D.C.] : , : [U.S. Government Publishing Office], , [2018] | ||
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Lo trovi qui: Univ. Federico II | ||
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PDUFA V [[electronic resource] ] : medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, July 7, 2011 |
Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2012 |
Descrizione fisica | 1 online resource (iii, 165 pages) : illustrations |
Soggetto topico |
Drug approval - United States
Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | PDUFA V |
Record Nr. | UNINA-9910702089503321 |
Washington : , : U.S. G.P.O., , 2012 | ||
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Lo trovi qui: Univ. Federico II | ||
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Q8(R1) pharmaceutical development revision 1 [electronic resource] |
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], , [2008?] |
Descrizione fisica | 1 online resource (14 pages) : illustrations (some color) |
Soggetto topico | Drug development - Government policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Q8 |
Record Nr. | UNINA-9910702187703321 |
[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], , [2008?] | ||
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Lo trovi qui: Univ. Federico II | ||
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