21st century cures : examining barriers to ongoing evidence development and communication : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 22, 2014 |
Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2015 |
Descrizione fisica | 1 online resource (iii, 128 pages) |
Soggetto topico |
Evidence-based medicine - United States
Communication in medicine - United States Drugs - United States - Testing Medical instruments and apparatus - United States - Testing |
Soggetto genere / forma | Legislative hearings. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | 21st century cures |
Record Nr. | UNINA-9910703871203321 |
Washington : , : U.S. Government Publishing Office, , 2015 | ||
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Lo trovi qui: Univ. Federico II | ||
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21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014 |
Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2015 |
Descrizione fisica | 1 online resource (iv, 165 pages) |
Soggetto topico |
Clinical trials - United States
Drugs - United States - Testing Medical instruments and apparatus - United States - Testing Clinical trials Drugs - Testing Medical instruments and apparatus - Testing |
Soggetto genere / forma | Legislative hearings. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | 21st century cures |
Record Nr. | UNINA-9910703523803321 |
Washington : , : U.S. Government Publishing Office, , 2015 | ||
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Lo trovi qui: Univ. Federico II | ||
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The adequacy of FDA to assure the safety of the nation's drug supply : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, February 13, March 22, 2007 |
Soggetto topico |
Drugs - United States - Testing
Pharmaceutical policy - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Adequacy of FDA to Assure the Safety of the Nation's Drug Supply |
Record Nr. | UNINA-9910694379003321 |
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Lo trovi qui: Univ. Federico II | ||
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Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017 |
Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2018 |
Descrizione fisica | 1 online resource (iv, 51 pages) |
Soggetto topico |
Drugs - United States - Testing
Drug approval - United States Drugs - Safety regulations - United States Medical instruments and apparatus - Safety regulations - United States Generic drugs - United States Competition - United States Antitrust law - United States Antitrust law Competition Drug approval Drugs - Safety regulations Drugs - Testing Generic drugs Medical instruments and apparatus - Safety regulations |
Soggetto genere / forma |
Legislative hearings.
Rules. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Antitrust concerns and the FDA approval process |
Record Nr. | UNINA-9910709758903321 |
Washington : , : U.S. Government Publishing Office, , 2018 | ||
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Lo trovi qui: Univ. Federico II | ||
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Center for Drug Evaluation and Research update |
Pubbl/distr/stampa | [Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] |
Descrizione fisica | 1 online resource |
Disciplina | 615 |
Soggetto topico |
Drugs - United States - Testing
Pharmaceutical policy - United States Drug approval - United States Drug approval Drugs - Testing Pharmaceutical policy Drug Approval Drug Industry |
Soggetto genere / forma |
Periodicals.
Statistics. Statistics |
ISSN | 2150-2390 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Periodico |
Lingua di pubblicazione | eng |
Altri titoli varianti |
Update
CDER ... update Improving public health through human drugs |
Record Nr. | UNINA-9910702844903321 |
[Silver Spring, MD], : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] | ||
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Lo trovi qui: Univ. Federico II | ||
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Challenges for the FDA [[electronic resource] ] : the future of drug safety : workshop summary / / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs |
Pubbl/distr/stampa | Washington, DC, : National Academies Press, c2007 |
Descrizione fisica | xvii, 109 p. : ill |
Altri autori (Persone) |
PrayLeslie A
RobinsonSally |
Soggetto topico |
Drugs - United States - Testing
Drugs - United States - Safety measures |
Soggetto genere / forma | Electronic books. |
ISBN |
1-281-09355-6
9786611093556 0-309-10987-6 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910451934203321 |
Washington, DC, : National Academies Press, c2007 | ||
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Lo trovi qui: Univ. Federico II | ||
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Challenges for the FDA [[electronic resource] ] : the future of drug safety : workshop summary / / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs |
Pubbl/distr/stampa | Washington, DC, : National Academies Press, c2007 |
Descrizione fisica | xvii, 109 p. : ill |
Altri autori (Persone) |
PrayLeslie A
RobinsonSally |
Soggetto topico |
Drugs - United States - Testing
Drugs - United States - Safety measures |
ISBN |
0-309-17944-0
1-281-09355-6 9786611093556 0-309-10987-6 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910778373603321 |
Washington, DC, : National Academies Press, c2007 | ||
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Lo trovi qui: Univ. Federico II | ||
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Challenges for the FDA [[electronic resource] ] : the future of drug safety : workshop summary / / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Washington, DC, : National Academies Press, c2007 |
Descrizione fisica | xvii, 109 p. : ill |
Altri autori (Persone) |
PrayLeslie A
RobinsonSally |
Soggetto topico |
Drugs - United States - Testing
Drugs - United States - Safety measures |
ISBN |
0-309-17944-0
1-281-09355-6 9786611093556 0-309-10987-6 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | FrontMatter -- Reviewers -- Preface -- Contents -- Tables, Figures, and Boxes -- Summary -- 1 Introduction -- 2 Addressing the FDA's Resource Challenges -- 3 Strengthening the Scientific Base of the Agency -- 4 Integrating Pre- and Postmarket Review -- 5 Enhancing Postmarket Safety Monitoring -- 6 Conducting Confirmatory Drug Safety and Efficacy Studies -- 7 Enhancing the Value of Clinical Trial Registration -- 8 Enhancing Postmarket Regulation and Enforcement -- 9 Looking to the Future -- References -- Appendixes -- Appendix A Workshop Agenda -- Appendix B Speaker Biographies. |
Record Nr. | UNINA-9910819115603321 |
Washington, DC, : National Academies Press, c2007 | ||
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Lo trovi qui: Univ. Federico II | ||
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Drug regulation reform--oversight : hearing before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-sixth Congress, second session . |
Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 1980- |
Descrizione fisica | 1 online resource |
Soggetto topico |
Pharmaceutical policy - United States
Drugs - United States - Testing Pharmaceutical industry - United States Drug Industry Pharmaceutical Preparations - standards Research - standards Drugs - Testing Pharmaceutical industry Pharmaceutical policy |
Soggetto genere / forma | Legislative hearings. |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | v. 1. New drug approval process -- v. 2. Orphan drugs. |
Altri titoli varianti | Drug regulation reform--oversight |
Record Nr. | UNINA-9910716970303321 |
Washington : , : U.S. G.P.O., , 1980- | ||
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Lo trovi qui: Univ. Federico II | ||
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Drug user fees [[electronic resource] ] : enhancing patient access and drug safety : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining enhancing patient access and drug safety relating to prescription drug user fees, including S. 484, March 14, 2007 |
Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
Descrizione fisica | iii, 85 pages : digital, PDF file |
Collana | S. hrg. |
Soggetto topico |
Drugs - United States - Safety measures
Drugs - United States - Testing User charges - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Drug user fees |
Record Nr. | UNINA-9910697645403321 |
Washington : , : U.S. G.P.O., , 2008 | ||
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Lo trovi qui: Univ. Federico II | ||
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