Literature DB >> 28774876

Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.

Ann T Farrell1, Kirsten B Goldberg1, Richard Pazdur1,2.   

Abstract

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Year:  2017        PMID： 28774876      PMCID： PMC5600139          DOI： 10.1182/blood-2017-04-742726

Source DB:  PubMed          Journal:  Blood        ISSN： 0006-4971            Impact factor:   22.113


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  5 in total

1.  Reevaluating Eligibility Criteria - Balancing Patient Protection and Participation in Oncology Trials.

Authors:  Julia A Beaver; Gwynn Ison; Richard Pazdur
Journal:  N Engl J Med       Date:  2017-04-20       Impact factor: 91.245

2.  Seamless Oncology-Drug Development.

Authors:  Tatiana M Prowell; Marc R Theoret; Richard Pazdur
Journal:  N Engl J Med       Date:  2016-04-13       Impact factor: 91.245

Review 3.  Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science.

Authors:  G M Blumenthal; K B Goldberg; R Pazdur
Journal:  Clin Pharmacol Ther       Date:  2017-04-04       Impact factor: 6.875

4.  Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey.

Authors:  R Zeiser; A Burchert; C Lengerke; M Verbeek; K Maas-Bauer; S K Metzelder; S Spoerl; M Ditschkowski; M Ecsedi; K Sockel; F Ayuk; S Ajib; F S de Fontbrune; I-K Na; L Penter; U Holtick; D Wolf; E Schuler; E Meyer; P Apostolova; H Bertz; R Marks; M Lübbert; R Wäsch; C Scheid; F Stölzel; R Ordemann; G Bug; G Kobbe; R Negrin; M Brune; A Spyridonidis; A Schmitt-Gräff; W van der Velden; G Huls; S Mielke; G U Grigoleit; J Kuball; R Flynn; G Ihorst; J Du; B R Blazar; R Arnold; N Kröger; J Passweg; J Halter; G Socié; D Beelen; C Peschel; A Neubauer; J Finke; J Duyster; N von Bubnoff
Journal:  Leukemia       Date:  2015-07-31       Impact factor: 11.528

5.  Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia.

Authors:  Stephen G O'Brien; François Guilhot; Richard A Larson; Insa Gathmann; Michele Baccarani; Francisco Cervantes; Jan J Cornelissen; Thomas Fischer; Andreas Hochhaus; Timothy Hughes; Klaus Lechner; Johan L Nielsen; Philippe Rousselot; Josy Reiffers; Giuseppe Saglio; John Shepherd; Bengt Simonsson; Alois Gratwohl; John M Goldman; Hagop Kantarjian; Kerry Taylor; Gregor Verhoef; Ann E Bolton; Renaud Capdeville; Brian J Druker
Journal:  N Engl J Med       Date:  2003-03-13       Impact factor: 91.245
  5 in total
  2 in total

Review 1.  The FDA Oncology Center of Excellence and precision medicine.

Authors:  Kirsten B Goldberg; Gideon M Blumenthal; Amy E McKee; Richard Pazdur
Journal:  Exp Biol Med (Maywood)       Date:  2017-11-06

2.  Unintended Regulatory Caused Early Death-A Difficult Endpoint in Cancer Patient Care and Treatment.

Authors:  Wolfgang E Berdel
Journal:  Cancers (Basel)       Date:  2021-03-22       Impact factor: 6.639
  2 in total

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