Literature DB >> 27739512

Precision medicine and the changing role of regulatory agencies.

Alasdair Breckenridge1, Hans-Georg Eichler2, Jonathan P Jarow3.   

Abstract

The growth of precision medicine presents challenges for the regulators of medicines, related to aspects that include the basis of evidence generation, patient involvement in the regulatory process, cost of new medicines and the need for new regulatory models. It also raises questions about the tolerance of risk, especially with early interventions for life-threatening diseases.

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Year:  2016        PMID: 27739512     DOI: 10.1038/nrd.2016.206

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


  4 in total

Review 1.  Learning versus confirming in clinical drug development.

Authors:  L B Sheiner
Journal:  Clin Pharmacol Ther       Date:  1997-03       Impact factor: 6.875

2.  A new initiative on precision medicine.

Authors:  Francis S Collins; Harold Varmus
Journal:  N Engl J Med       Date:  2015-01-30       Impact factor: 91.245

Review 3.  Advancing the science of medicines regulation: the role of the 21st-century medicines regulator.

Authors:  M M Lumpkin; H-G Eichler; A Breckenridge; M A Hamburg; T Lönngren; K Woods
Journal:  Clin Pharmacol Ther       Date:  2012-09-05       Impact factor: 6.875

4.  Drug Regulation and Pricing--Can Regulators Influence Affordability?

Authors:  Hans-Georg Eichler; Hugo Hurts; Karl Broich; Guido Rasi
Journal:  N Engl J Med       Date:  2016-05-12       Impact factor: 91.245

  4 in total
  4 in total

1.  Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers.

Authors:  H Kim Lyerly; Jun Ren; Renzo Canetta; Gi Hyun Kim; Sumimasa Nagai; Tomohiro Yamaguchi; Ken Hatogai; Hiroshi Katayama; Silvy Da Rocha Dias; Daniel McManus; Kathy Soltys; Zhimin Yang; Olufumilayo Olopade; Nancy Goodman; Greg Reaman; Thomas Gross
Journal:  J Glob Oncol       Date:  2018-12

2.  The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.

Authors:  Melanie McPhail; Christopher McCabe; Dean A Regier; Tania Bubela
Journal:  Healthc Policy       Date:  2022-02

Review 3.  Personalized or Precision Medicine? The Example of Cystic Fibrosis.

Authors:  Fernando A L Marson; Carmen S Bertuzzo; José D Ribeiro
Journal:  Front Pharmacol       Date:  2017-06-20       Impact factor: 5.810

Review 4.  Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations.

Authors:  Peter G M Mol; Aliza Thompson; Hiddo J L Heerspink; Hubert G M Leufkens
Journal:  Diabetes Obes Metab       Date:  2018-10       Impact factor: 6.577

  4 in total

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