Literature DB >> 22164188

Registries, research, and regrets: is the FDA's post-marketing REMS process not adequately protecting patients?

Norman J Kachuck.   

Abstract

Entities:  

Year:  2011        PMID： 22164188      PMCID： PMC3229256          DOI： 10.1177/1756285611424461

Source DB:  PubMed          Journal:  Ther Adv Neurol Disord        ISSN： 1756-2856            Impact factor:   6.570


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  10 in total

1.  Shattuck lecture. Innovation, regulation, and the FDA.

Authors:  Margaret A Hamburg
Journal:  N Engl J Med       Date:  2010-12-02       Impact factor: 91.245

2.  Effect of internal reporting criteria on suspected adverse drug reactions submitted to MedWatch.

Authors:  Kelly M Smith; Amber P Lawson; Sony Tuteja
Journal:  Am J Health Syst Pharm       Date:  2006-05-15       Impact factor: 2.637

Review 3.  The REMS publication paradox.

Authors:  Elizabeth B Andrews; James A Kaye; Carla Van Bennekom
Journal:  Oncology (Williston Park)       Date:  2009-07       Impact factor: 2.990

4.  Reemergence of PML in natalizumab-treated patients--new cases, same concerns.

Authors:  Eugene O Major
Journal:  N Engl J Med       Date:  2009-09-10       Impact factor: 91.245

5.  New FDA regulation to improve safety reporting in clinical trials.

Authors:  Rachel Behrman Sherman; Janet Woodcock; Janet Norden; Cheryl Grandinetti; Robert J Temple
Journal:  N Engl J Med       Date:  2011-06-08       Impact factor: 91.245

6.  Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems.

Authors:  D A Kessler
Journal:  JAMA       Date:  1993-06-02       Impact factor: 56.272

7.  A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

Authors:  Priscilla Velentgas; Rhonda L Bohn; Jeffrey S Brown; K Arnold Chan; Patricia Gladowski; Crystal N Holick; Judith M Kramer; Cynthia Nakasato; Claire M Spettell; Alexander M Walker; Fang Zhang; Richard Platt
Journal:  Pharmacoepidemiol Drug Saf       Date:  2008-12       Impact factor: 2.890

8.  Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems.

Authors:  Rita Shane
Journal:  Am J Health Syst Pharm       Date:  2009-12-15       Impact factor: 2.637

9.  Asymptomatic reactivation of JC virus in patients treated with natalizumab.

Authors:  Yiping Chen; Evelyn Bord; Troy Tompkins; Janice Miller; Chen S Tan; R Philip Kinkel; Marion C Stein; Raphael P Viscidi; Long H Ngo; Igor J Koralnik
Journal:  N Engl J Med       Date:  2009-09-10       Impact factor: 91.245

10.  Progressive multifocal leukoencephalopathy after natalizumab monotherapy.

Authors:  Hans Lindå; Anders von Heijne; Eugene O Major; Caroline Ryschkewitsch; Johan Berg; Tomas Olsson; Claes Martin
Journal:  N Engl J Med       Date:  2009-09-10       Impact factor: 91.245
  10 in total
  3 in total

1.  Medical decisions are not just about the facts: What a life-threatening virus can teach us about empathy, psychology, and the practice of neurology.

Authors:  Norman J Kachuck
Journal:  Neurol Clin Pract       Date:  2012-06

2.  Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

Authors:  Brent D Kerger; Autumn Bernal; Dennis J Paustenbach; Gavin Huntley-Fenner
Journal:  BMC Public Health       Date:  2016-09-15       Impact factor: 3.295

Review 3.  Risk evaluation and monitoring in multiple sclerosis therapeutics.

Authors:  Michel C Clanet; Jerry S Wolinsky; Raymond J Ashton; Hans-Peter Hartung; Stephen C Reingold
Journal:  Mult Scler       Date:  2013-11-30       Impact factor: 6.312
  3 in total

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