Challenges for the FDA : 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

• Pubblicazione: Washington, DC, : National Academies Press, c2007
• Edizione: 1st ed.
• Descrizione fisica: xvii, 109 p. : ill
• Soggetto topico: Drugs - United States - Testing; Drugs - United States - Safety measures
• Altri autori: PrayLeslie A RobinsonSally
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references (p. 78-79).
• 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.
• Titolo autorizzato: Challenges for the FDA
• ISBN: 0-309-17944-0; 1-281-09355-6; 9786611093556; 0-309-10987-6
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910974219603321
• Lo trovi qui: Univ. Federico II