Literature DB >> 26435528

Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.

Nicholas S Downing1, Harlan M Krumholz1,2, Joseph S Ross1,2, Nilay D Shah3.   

Abstract

Mesh：

Year:  2015        PMID： 26435528     DOI： 10.1038/nrd4734

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  4 in total

1.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

2.  Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework.

Authors:  Oriana Ciani; Marc Buyse; Mike Drummond; Guido Rasi; Everardo D Saad; Rod S Taylor
Journal:  Nat Rev Drug Discov       Date:  2016-06-03       Impact factor: 84.694

3.  Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.

Authors:  Matthieu Larochelle; Nicholas S Downing; Joseph S Ross; Frank S David
Journal:  BMJ Open       Date:  2017-02-08       Impact factor: 2.692

4.  Time to market for drugs approved in Canada between 2014 and 2018: an observational study.

Authors:  Joel Lexchin
Journal:  BMJ Open       Date:  2021-07-05       Impact factor: 2.692
  4 in total

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