Literature DB >> 29871508

Expediting drug development for serious illness: Trade-offs between patient access and certainty.

Janet Woodcock1.   

Abstract

Entities:  

Mesh：

Year:  2018        PMID： 29871508     DOI： 10.1177/1740774518770656

Source DB:  PubMed          Journal:  Clin Trials        ISSN： 1740-7745            Impact factor:   2.486


× No keyword cloud information.
  5 in total

1.  A framework for assessing the impact of accelerated approval.

Authors:  A Lawrence Gould; Robert K Campbell; John W Loewy; Robert A Beckman; Jyotirmoy Dey; Anja Schiel; Carl-Fredrik Burman; Joey Zhou; Zoran Antonijevic; Eva R Miller; Rui Tang
Journal:  PLoS One       Date:  2022-06-24       Impact factor: 3.752

2.  Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.

Authors:  Matthew Herder
Journal:  Milbank Q       Date:  2019-08-12       Impact factor: 4.911

3.  Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey.

Authors:  Ran D Goldman; Shashidhar R Marneni; Michelle Seiler; Julie C Brown; Eileen J Klein; Cristina Parra Cotanda; Renana Gelernter; Tyler D Yan; Julia Hoeffe; Adrienne L Davis; Mark A Griffiths; Jeanine E Hall; Gianluca Gualco; Ahmed Mater; Sergio Manzano; Graham C Thompson; Sara Ahmed; Samina Ali; Naoki Shimizu
Journal:  Clin Ther       Date:  2020-10-03       Impact factor: 3.393

4.  Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non-orphan, Non-oncology Drugs in the European Union and United States from 2012-2016.

Authors:  Anne Vinther Morant; Vivien Jagalski; Henrik Tang Vestergaard
Journal:  Clin Transl Sci       Date:  2019-03-02       Impact factor: 4.689

5.  Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.

Authors:  Erica M Cox; Anita V Edmund; Erica Kratz; Sarah H Lockwood; Aishwarya Shankar
Journal:  Clin Transl Sci       Date:  2020-02-06       Impact factor: 4.689
  5 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.