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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
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
Materiale a stampa
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
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
Materiale a stampa
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
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
Materiale a stampa
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
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
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Center for Drug Evaluation and Research update
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]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
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
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
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
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
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
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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 .
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-
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
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
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
Materiale a stampa
Lo trovi qui: Univ. Federico II
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