Literature DB >> 26391294

FDA Policy and Cardiovascular Medicine.

Joseph S Ross1, Aaron S Kesselheim2.   

Abstract

Entities:  

Keywords:  health policy; medical therapy; pharmaceutical safety

Mesh：

Substances：

Year:  2015        PMID： 26391294      PMCID： PMC4586041          DOI： 10.1161/CIRCULATIONAHA.114.010295

Source DB:  PubMed          Journal:  Circulation        ISSN： 0009-7322            Impact factor:   29.690


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  57 in total

Review 1.  The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA.

Authors:  S R Shulman; K I Kaitin
Journal:  Pharmacoeconomics       Date:  1996-02       Impact factor: 4.981

2.  Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine.

Authors:  Aaron V Kaplan; Elisa D Harvey; Richard E Kuntz; Hadas Shiran; John F Robb; Peter Fitzgerald
Journal:  Circulation       Date:  2005-11-01       Impact factor: 29.690

3.  Approval times for new drugs: does the source of funding for FDA staff matter?

Authors:  Daniel Carpenter; Michael Chernew; Dean G Smith; A Mark Fendrick
Journal:  Health Aff (Millwood)       Date:  2003 Jul-Dec       Impact factor: 6.301

4.  Surrogate endpoints and FDA's accelerated approval process.

Authors:  Thomas R Fleming
Journal:  Health Aff (Millwood)       Date:  2005 Jan-Feb       Impact factor: 6.301

5.  Semper fidelis--consumer protection for patients with implanted medical devices.

Authors:  William H Maisel
Journal:  N Engl J Med       Date:  2008-03-06       Impact factor: 91.245

6.  Drug-review deadlines and safety problems.

Authors:  Daniel Carpenter; Evan James Zucker; Jerry Avorn
Journal:  N Engl J Med       Date:  2008-03-27       Impact factor: 91.245

Review 7.  Surrogate end points in clinical trials: are we being misled?

Authors:  T R Fleming; D L DeMets
Journal:  Ann Intern Med       Date:  1996-10-01       Impact factor: 25.391

8.  Generic substitution of pharmaceuticals.

Authors:  M Bollen
Journal:  Aust Fam Physician       Date:  1994-12

9.  Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.

Authors:  Steven E Nissen; Kathy Wolski
Journal:  N Engl J Med       Date:  2007-05-21       Impact factor: 91.245

10.  The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions.

Authors:  William H Shrank; Tuyen Hoang; Susan L Ettner; Peter A Glassman; Kavita Nair; Dee DeLapp; June Dirstine; Jerry Avorn; Steven M Asch
Journal:  Arch Intern Med       Date:  2006-02-13
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  2 in total

1.  US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

Authors:  Joshua J Skydel; Audrey D Zhang; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal:  Clin Trials       Date:  2021-04-16       Impact factor: 2.486

2.  Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.

Authors:  Joshua J Skydel; Anita T Luxkaranayagam; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal:  JAMA Netw Open       Date:  2019-05-03
  2 in total

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