Literature DB >> 23034017

User fees and beyond--the FDA Safety and Innovation Act of 2012.

Daniel B Kramer1, Aaron S Kesselheim.   

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Year:  2012        PMID： 23034017      PMCID： PMC4258823          DOI： 10.1056/NEJMp1207800

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  2 in total

1.  Regulatory review of novel therapeutics--comparison of three regulatory agencies.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Joel B Braunstein; Harlan M Krumholz; Joseph S Ross
Journal:  N Engl J Med       Date:  2012-05-16       Impact factor: 91.245

2.  Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

Authors:  Samantha A Roberts; Jeff D Allen; Ellen V Sigal
Journal:  Health Aff (Millwood)       Date:  2011-06-16       Impact factor: 6.301
  2 in total
  8 in total

Review 1.  The changing landscape of phase I trials in oncology.

Authors:  Kit Man Wong; Anna Capasso; S Gail Eckhardt
Journal:  Nat Rev Clin Oncol       Date:  2015-11-10       Impact factor: 66.675

Review 2.  Approval of high-risk medical devices in the US: implications for clinical cardiology.

Authors:  Benjamin N Rome; Daniel B Kramer; Aaron S Kesselheim
Journal:  Curr Cardiol Rep       Date:  2014       Impact factor: 2.931

3.  Practical Improvements for Medical Device Evaluation.

Authors:  Daniel B Kramer; Robert W Yeh
Journal:  JAMA       Date:  2017-07-25       Impact factor: 56.272

4.  Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.

Authors:  Daniel B Kramer; Yongtian T Tan; Chiaki Sato; Aron S Kesselheim
Journal:  Food Drug Law J       Date:  2014       Impact factor: 0.619

Review 5.  The most transformative drugs of the past 25 years: a survey of physicians.

Authors:  Aaron S Kesselheim; Jerry Avorn
Journal:  Nat Rev Drug Discov       Date:  2013-05-17       Impact factor: 84.694

6.  Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices.

Authors:  Vinay Prasad; John Pa Ioannidis
Journal:  Implement Sci       Date:  2014-01-08       Impact factor: 7.327

7.  Cybersecurity features of digital medical devices: an analysis of FDA product summaries.

Authors:  Ariel Dora Stern; William J Gordon; Adam B Landman; Daniel B Kramer
Journal:  BMJ Open       Date:  2019-06-28       Impact factor: 2.692

8.  Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

Authors:  Aaron S Kesselheim; Shuai Xu; Jerry Avorn
Journal:  PLoS One       Date:  2014-02-12       Impact factor: 3.240
  8 in total

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