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 |
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 |
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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Follow-on biologics [[electronic resource] ] : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007 |
Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
Descrizione fisica | 1 electronic text (iv, 78 pages) : HTML, digital, PDF file |
Collana | S. hrg. |
Soggetto topico |
Pharmaceutical biotechnology - Government policy - United States
Pharmaceutical biotechnology - United States Pharmaceutical technology - Government policy - United States Drug development - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Follow-on biologics |
Record Nr. | UNINA-9910698695203321 |
Washington : , : U.S. G.P.O., , 2008 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products |
Pubbl/distr/stampa | [Rockville, MD] : , : Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [1995] |
Descrizione fisica | 1 online resource (i, 16 pages) |
Soggetto topico |
Drugs - Testing - Government policy - United States
Pharmaceutical biotechnology - Government policy - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910690381003321 |
[Rockville, MD] : , : Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [1995] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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