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Biologics and biosimilars [[electronic resource] ] : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009
| Biologics and biosimilars [[electronic resource] ] : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2010 |
| Descrizione fisica | 1 online resource (iv, 252 pages) : illustrations |
| Soggetto topico |
Drug development - Government policy - United States
Pharmaceutical biotechnology - Government policy - United States Pharmaceutical biotechnology - United States Biologicals - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Biologics and biosimilars |
| Record Nr. | UNINA-9910698589103321 |
| Washington : , : U.S. G.P.O., , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Emerging health care issues [[electronic resource] ] : follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009
| Emerging health care issues [[electronic resource] ] : follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2012 |
| Descrizione fisica | 1 online resource (vi, 283 pages) : illustrations |
| Soggetto topico |
Biologicals - Government policy - United States
Pharmaceutical biotechnology - Government policy - United States Drugs - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Emerging health care issues |
| Record Nr. | UNINA-9910703347403321 |
| Washington : , : U.S. G.P.O., , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Examining implementation of the Biologics Price Competition and Innovation Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016
| Examining implementation of the Biologics Price Competition and Innovation Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2016 |
| Descrizione fisica | 1 online resource (iii, 83 pages) |
| Soggetto topico |
Biologicals - Government policy - United States
Pharmaceutical biotechnology - Government policy - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Examining implementation of the Biologics Price Competition and Innovation Act |
| Record Nr. | UNINA-9910707992303321 |
| Washington : , : U.S. Government Publishing Office, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997
| Guidance for industry [[electronic resource] ] : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997 |
| 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 | 22 pages : digital, PDF file |
| Soggetto topico |
Pharmaceutical industry - Government policy - 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-9910698811003321 |
| 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 | ||
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Guidance for industry [[electronic resource] ] : FDA export certificates
| Guidance for industry [[electronic resource] ] : FDA export certificates |
| 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 : , : Center for Food Safety and Applied Nutrition, , [2005] |
| Descrizione fisica | 6 pages : digital, PDF file |
| Soggetto topico |
Export controls - United States
Biologicals - Government policy - United States Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698836803321 |
Guidance for industry [[electronic resource] ] : development and use of risk minimization action plans
| Guidance for industry [[electronic resource] ] : development and use of risk minimization action plans |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2005] |
| Descrizione fisica | 1 online resource (23 pages) |
| Soggetto topico |
Drugs - Side effects - Prevention - Government policy - 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-9910699060503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2005] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 | ||
| ||
Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012
| Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2013 |
| Descrizione fisica | 1 online resource (iv, 194 pages) : illustrations |
| Soggetto topico |
Drug approval - United States
Generic drugs - Government policy - United States Biologicals - Government policy - United States Drug accessibility - United States Fees, Administrative - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages |
| Record Nr. | UNINA-9910704729003321 |
| Washington : , : U.S. Government Printing Office, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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