Require Evaluation before Implementing Executive Wishlists (REVIEW) Act of 2015; and the Regulatory Predictability for Business Growth Act of 2015 : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fourteenth Congress, first session on H.R. 3438 and H.R. 2631, November 3, 2015

• Record Nr.: UNINA9910704251103321
• Pubbl/distr/stampa: Washington : , : U.S. Government Publishing Office, , 2016
• Descrizione fisica: 1 online resource (iv, 87 pages)
• Soggetti: Administrative acts - United States; Administrative procedure - United States; Judicial review of administrative acts - United States; Administrative acts; Administrative procedure; Judicial review of administrative acts; Legislative hearings.; United States
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Title from title screen (viewed on Jan. 28, 2016).; Paper version available for sale by the Superintendent of Documents, United States Government Publishing Office.; "Serial no. 114-51."
• Nota di bibliografia: Includes bibliographical references.

Emerging safety science : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies

• Record Nr.: UNINA9910964101503321
• Pubbl/distr/stampa: Washington, D.C., : National Academies Press, c2008
• ISBN: 0-309-17817-7; 1-281-30023-3; 9786611300234; 0-309-11013-0
• Edizione: [1st ed.]
• Descrizione fisica: xvi, 134 p. : ill. (some col.)
• Altri autori (Persone): RobinsonSally; PoolRobert; GiffinRobert B
• Disciplina: 615/.10289
• Soggetti: Drugs - United States - Safety measures; Pharmaceutical biotechnology - United States; Drugs - United States - Design
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Workshop held April 23-24, 2007 in Silver Spring, MD.
• Nota di bibliografia: Includes bibliographical references (p. 115-116).
• Nota di contenuto: Front Matter -- Reviewers -- Preface -- Contents -- Tables and Figures -- 1 Introduction -- 2 Investigative Toxicology: The State of the Art -- 3 Screening Technologies I: Human Cell-Based Approaches -- 4 Screening Technologies II: Toxicogenomics -- 5 Screening Technologies III: Metabolomics -- 6 Screening Technologies IV: Pharmacogenetics -- 7 Qualifying Biomarkers -- 8 Pharmacovigilance -- 9 Integration -- 10 The Future of Safety Science -- References -- Appendixes -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographies.
• Sommario/riassunto: In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs ; that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.