Literature DB >> 27681787

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

Sean Khozin1, Meredith Chuk1, Tamy Kim1, Geoffrey Kim1, Richard Pazdur1, Suranjan De2, Sanjay Sahoo2.   

Abstract

Mesh：

Year:  2016        PMID： 27681787     DOI： 10.1038/nrd.2016.189

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


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  3 in total

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

Authors:  Elad Sharon
Journal:  Clin Trials       Date:  2017-03-26       Impact factor: 2.486

2.  INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.

Authors:  Sean Khozin; Richard Pazdur; Anand Shah
Journal:  Nat Rev Drug Discov       Date:  2018-04-06       Impact factor: 84.694

Review 3.  Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Authors:  Gita Thanarajasingam; Lori M Minasian; Frederic Baron; Franco Cavalli; R Angelo De Claro; Amylou C Dueck; Tarec C El-Galaly; Neil Everest; Jan Geissler; Christian Gisselbrecht; John Gribben; Mary Horowitz; S Percy Ivy; Caron A Jacobson; Armand Keating; Paul G Kluetz; Aviva Krauss; Yok Lam Kwong; Richard F Little; Francois-Xavier Mahon; Matthew J Matasar; María-Victoria Mateos; Kristen McCullough; Robert S Miller; Mohamad Mohty; Philippe Moreau; Lindsay M Morton; Sumimasa Nagai; Simon Rule; Jeff Sloan; Pieter Sonneveld; Carrie A Thompson; Kyriaki Tzogani; Flora E van Leeuwen; Galina Velikova; Diego Villa; John R Wingard; Sophie Wintrich; John F Seymour; Thomas M Habermann
Journal:  Lancet Haematol       Date:  2018-06-18       Impact factor: 18.959
  3 in total

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