Literature DB >> 28345419

Commentary on Perez et al.: How to create a 21st century adverse event reporting system.

Elad Sharon1.   

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Year:  2017        PMID： 28345419      PMCID： PMC7372949          DOI： 10.1177/1740774517700641

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


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  7 in total

1.  The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety.

Authors:  Melissa A Robb; Judith A Racoosin; Rachel E Sherman; Thomas P Gross; Robert Ball; Marsha E Reichman; Karen Midthun; Janet Woodcock
Journal:  Pharmacoepidemiol Drug Saf       Date:  2012-01       Impact factor: 2.890

2.  The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.

Authors:  Jonathan P Jarow; Sandra Casak; Meredith Chuk; Lori A Ehrlich; Sean Khozin
Journal:  Clin Cancer Res       Date:  2016-01-18       Impact factor: 12.531

3.  Developing the Sentinel System--a national resource for evidence development.

Authors:  Rachel E Behrman; Joshua S Benner; Jeffrey S Brown; Mark McClellan; Janet Woodcock; Richard Platt
Journal:  N Engl J Med       Date:  2011-01-12       Impact factor: 91.245

Review 4.  Regulatory watch: From big data to smart data: FDA's INFORMED initiative.

Authors:  Sean Khozin; Geoffrey Kim; Richard Pazdur
Journal:  Nat Rev Drug Discov       Date:  2017-02-24       Impact factor: 84.694

5.  The immuno-oncology race: myths and emerging realities.

Authors:  Stephen Cavnar; Pedro Valencia; Jesse Brock; Judith Wallenstein; Valery Panier
Journal:  Nat Rev Drug Discov       Date:  2017-02-02       Impact factor: 84.694

6.  Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA.

Authors:  Sean Khozin; Meredith Chuk; Tamy Kim; Geoffrey Kim; Richard Pazdur; Suranjan De; Sanjay Sahoo
Journal:  Nat Rev Drug Discov       Date:  2016-09-29       Impact factor: 84.694

7.  Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Authors:  Raymond Perez; Patrick Archdeacon; Nancy Roach; Robert Goodwin; Jonathan Jarow; Nina Stuccio; Annemarie Forrest
Journal:  Clin Trials       Date:  2017-03-26       Impact factor: 2.486
  7 in total

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