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An Act to Educate Health Care Providers and the Public on Biosimilar Biological Products, and for Other Purposes
| An Act to Educate Health Care Providers and the Public on Biosimilar Biological Products, and for Other Purposes |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] |
| Descrizione fisica | 1 online resource (2 unnumbered pages) |
| Soggetto topico |
Health education - Law and legislation - United States
Biologicals - United States Biologicals Health education - Law and legislation |
| Soggetto genere / forma | Statutes and codes. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910716074103321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Assessing the impact of a safe and equitable biosimilar policy in the United States : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007
| Assessing the impact of a safe and equitable biosimilar policy in the United States : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007 |
| Descrizione fisica | 1 online resource (vi, 184 p.) : ill |
| Soggetto topico |
Biologicals - United States
Pharmaceutical biotechnology - United States Generic drugs - United States |
| Soggetto non controllato |
Biologicals
Pharmaceutical biotechnology Generic drugs Medical Technology & engineering |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States |
| Record Nr. | UNINA-9910694419603321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products [[electronic resource]]
| Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1996] |
| Descrizione fisica | 1 electronic resource |
| Soggetto topico | Biologicals - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products |
| Record Nr. | UNINA-9910696917903321 |
| Rockville, MD : , : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1996] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
| Guidance for industry [[electronic resource] ] : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, , [2008] |
| Descrizione fisica | i, 6 pages : digital, PDF file |
| Soggetto topico |
Containers - Testing
Caps and closures - United States - Testing Biologicals - United States Drugs - United States Medical instruments and apparatus - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698710903321 |
Guidance for industry [[electronic resource] ] : characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases
| Guidance for industry [[electronic resource] ] : characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2006] |
| Descrizione fisica | ii, 49 pages : digital, PDF file |
| Soggetto topico |
Biologicals - United States
Viral vaccines - United States Communicable diseases - United States - Prevention |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698854603321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information
| Guidance for industry [[electronic resource] ] : IND meetings for human drugs and biologics, 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 : , : Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | 1 electronic resource (10 pages) |
| Soggetto topico |
Medicine, Experimental - Government policy - United States
Biologicals - United States Drug approval - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696912703321 |
| 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] ] : providing clinical evidence of effectiveness for human drug and biological products
| Guidance for industry [[electronic resource] ] : providing clinical evidence of effectiveness for human drug and biological products |
| 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, , [1998] |
| Descrizione fisica | 1 online resource (20 pages) |
| Soggetto topico |
Drugs - Effectiveness - United States
Biologicals - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699353803321 |
| 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, , [1998] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : changes to an approved application for specified biotechnology and specified synthetic biological products
| Guidance for industry [[electronic resource] ] : changes to an approved application for specified biotechnology and specified synthetic biological products |
| Pubbl/distr/stampa | [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1997] |
| Descrizione fisica | 1 electronic research (i, 8 pages) |
| Soggetto topico |
Biotechnology - United States
Biologicals - United States Drug approval - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696922503321 |
| [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Drug Evaluation and Research, , [1997] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007
| Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007 |
| Descrizione fisica | 1 online resource (iv, 274 p.) : ill |
| Soggetto topico |
Biologicals - United States
Pharmaceutical biotechnology - United States Generic drugs - United States |
| Soggetto non controllato |
Biologicals
Pharmaceutical biotechnology Generic drugs Medical Technology & engineering |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Safe and affordable biotech drugs |
| Record Nr. | UNINA-9910694411303321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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