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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 | ||
| ||
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 : 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 : 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 | ||
| ||
CAPA for the FDA-regulated industry / / José Rodríguez Pérez
| CAPA for the FDA-regulated industry / / José Rodríguez Pérez |
| Autore | Rodríguez Pérez José <1961-> |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2010 |
| Descrizione fisica | 1 online resource (166 p.) |
| Disciplina | 615.1068/1 |
| Soggetto topico |
Pharmaceutical industry - Government policy - United States
Food industry and trade - Government policy - United States Total quality management - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
600-00-4955-2
1-62198-309-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910464171603321 |
Rodríguez Pérez José <1961->
|
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
CBO's model of drug price negotiations under the Elijah E. Cummings Lower Drug Costs Now Act / / Christopher Adams and Evan Herrnstadt
| CBO's model of drug price negotiations under the Elijah E. Cummings Lower Drug Costs Now Act / / Christopher Adams and Evan Herrnstadt |
| Autore | Adams Christopher P. |
| Pubbl/distr/stampa | Washington, D.C. : , : Congressional Budget Office, , 2021 |
| Descrizione fisica | 1 online resource (approximately 31 pages) : color illustrations |
| Collana | Working paper |
| Soggetto topico |
Prescription pricing - Government policy - United States
Pharmaceutical industry - Government policy - United States Drugs - Prices - United States Drugs - United States - Cost control Drugs - Law and legislation - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Congressional Budget Office's model of drug price negotiations under the Elijah E. Cummings Lower Drug Costs Now Act |
| Record Nr. | UNINA-9910716839803321 |
|
Adams Christopher P.
|
||
| Washington, D.C. : , : Congressional Budget Office, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A continuing investigation into the fungal meningitis outbreak and whether it could have been prevented : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, April 16, 2013
| A continuing investigation into the fungal meningitis outbreak and whether it could have been prevented : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, April 16, 2013 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2015 |
| Descrizione fisica | 1 online resource (v, 134 pages) |
| Soggetto topico |
Meningitis - United States - Prevention
Drugs - Dosage forms - Health aspects - United States Drug factories - Inspection - United States Pharmaceutical industry - Government policy - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Continuing investigation into the fungal meningitis outbreak and whether it could have been prevented |
| Record Nr. | UNINA-9910703514803321 |
| Washington : , : U.S. Government Printing Office, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Examining drug compounding : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, May 23, 2013
| Examining drug compounding : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, May 23, 2013 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (v, 167 pages) |
| Soggetto topico |
Drugs - Dosage forms - United States
Drug factories - Inspection - United States Pharmaceutical industry - Government policy - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Examining drug compounding |
| Record Nr. | UNINA-9910705346303321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Examining implementation of the Compounding Quality Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, second session, January 30, 2018
| Examining implementation of the Compounding Quality Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, second session, January 30, 2018 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2019 |
| Descrizione fisica | 1 online resource (vi, 286 pages) : illustrations |
| Soggetto topico |
Drugs - Dosage forms - Government policy - United States
Pharmaceutical industry - Government policy - United States Drug adulteration - United States - Prevention |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Examining implementation of the Compounding Quality Act |
| Record Nr. | UNINA-9910711803803321 |
| Washington : , : U.S. Government Publishing Office, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The fungal meningitis outbreak : could it have been prevented? : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, November 14, 2012
| The fungal meningitis outbreak : could it have been prevented? : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, November 14, 2012 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 293 pages) : illustration |
| Soggetto topico |
Meningitis - United States - Prevention
Drugs - Dosage forms - Health aspects - United States Drug factories - Inspection - United States Pharmaceutical industry - Government policy - United States |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Fungal meningitis outbreak |
| Record Nr. | UNINA-9910702543803321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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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