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An Act to Extend the Pediatric Priority Review Voucher Program
| An Act to Extend the Pediatric Priority Review Voucher Program |
| Edizione | [[Corrected printing].] |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] |
| Descrizione fisica | 1 online resource (4 unnumbered pages) |
| Soggetto topico |
Pediatric pharmacology - Government policy - United States
Drugs - Testing - Law and legislation - United States Drug development - Government policy - United States |
| Soggetto genere / forma | Statutes and codes. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910707734403321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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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Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs
| Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2011 |
| Descrizione fisica | 1 online resource (95 p.) |
| Disciplina | 615.1 |
| Altri autori (Persone) |
LebovitzYeonwoo
EnglishRebecca A ClaiborneAnne B |
| Soggetto topico |
Pharmaceutical policy - United States
Drug development - Government policy - United States Pharmaceutical industry - Government policy - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-283-01910-8
9786613019103 0-309-15890-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910457137103321 |
| Washington, D.C., : National Academies Press, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs
| Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2011 |
| Descrizione fisica | 1 online resource (95 p.) |
| Disciplina | 615.1 |
| Altri autori (Persone) |
LebovitzYeonwoo
EnglishRebecca A ClaiborneAnne B |
| Soggetto topico |
Pharmaceutical policy - United States
Drug development - Government policy - United States Pharmaceutical industry - Government policy - United States |
| ISBN |
0-309-20959-5
1-283-01910-8 9786613019103 0-309-15890-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910781299503321 |
| Washington, D.C., : National Academies Press, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs
| Building a national framework for the establishment of regulatory science for drug development [[electronic resource] ] : workshop summary / / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Washington, D.C. : , : National Academies Press, , 2011 |
| Descrizione fisica | 1 online resource (95 pages) |
| Disciplina | 615.1 |
| Altri autori (Persone) |
LebovitzYeonwoo
EnglishRebecca A ClaiborneAnne B |
| Soggetto topico |
Pharmaceutical policy - United States
Drug development - Government policy - United States Pharmaceutical industry - Government policy - United States |
| ISBN |
0-309-20959-5
1-283-01910-8 9786613019103 0-309-15890-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies"" |
| Record Nr. | UNINA-9910828319503321 |
| Washington, D.C. : , : National Academies Press, , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
FDA checkup : drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013
| FDA checkup : drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 87 pages) |
| Soggetto topico |
Drug development - Government policy - United States
Drug approval - United States Drugs - Testing - Government policy - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA checkup |
| Record Nr. | UNINA-9910705311003321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| 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
| 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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Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases [[electronic resource] ] : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C
| Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases [[electronic resource] ] : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2011 |
| Descrizione fisica | 1 online resource (iii, 58 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Rare diseases - Treatment
Tropical medicine Orphan drugs - United States Drug development - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases |
| Record Nr. | UNINA-9910703191803321 |
| Washington : , : U.S. G.P.O., , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : Q3B(R2) impurities in new drug products
| Guidance for industry [[electronic resource] ] : Q3B(R2) impurities in new drug products |
| 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 | 8 pages : digital, PDF file |
| Soggetto topico |
Drug development - Government policy - United States
Drug adulteration - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698987503321 |
| 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] ] : quality systems approach to pharmaceutical CGMP regulations
| Guidance for industry [[electronic resource] ] : quality systems approach to pharmaceutical CGMP regulations |
| 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 (28 pages) |
| Soggetto topico |
Quality of products - United States
Drug development - Government policy - United States Risk management - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699116603321 |
| 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 | ||
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