Literature DB >> 26785350

Breakthrough Medical Devices and the 21st Century Cures Act.

Aaron S Kesselheim, Thomas J Hwang.   

Abstract

Mesh：

Year:  2016        PMID： 26785350     DOI： 10.7326/M15-1906

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN： 0003-4819            Impact factor:   25.391


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  4 in total

Review 1.  Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad.

Authors:  Kimberly A Selzman; Hetal Patel; Kenneth Cavanaugh
Journal:  J Interv Card Electrophysiol       Date:  2019-08-16       Impact factor: 1.900

2.  Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Authors:  Sanket S Dhruva; Jonathan J Darrow; Aaron S Kesselheim; Rita F Redberg
Journal:  J Gen Intern Med       Date:  2022-02-09       Impact factor: 5.128

3.  Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.

Authors:  Thomas J Hwang; Elisaveta Sokolov; Jessica M Franklin; Aaron S Kesselheim
Journal:  BMJ       Date:  2016-06-28

4.  Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.

Authors:  Sana R Mostaghim; Joshua J Gagne; Aaron S Kesselheim
Journal:  BMJ       Date:  2017-09-07
  4 in total

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