Literature DB >> 22343812

Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?

J Woodcock1.   

Abstract

As the pharmaceutical industry productivity crisis worsens, there are calls for regulatory changes to support innovation. At the same time, prescribers and payers desire more information about drugs at the time they are released to the market. Will new regulatory schemes be able to accommodate these disparate needs?

Mesh：

Year:  2012        PMID： 22343812     DOI： 10.1038/clpt.2011.337

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  6 in total

1.  Recognizing that Evidence is Made, not Born.

Authors:  Robyn Lim; David K Lee; Pierre Sabourin; John Ferguson; Marilyn Metcalf; Meredith Smith; Solange Corriol-Rohou; Hans-Georg Eichler; Murray Lumpkin; Gigi Hirsch; Inhua Muijrers Chen; Brian O'Rourke; Anja Schiel; Nick Crabb; Naomi Aronson; Edmund Pezalla; Marc Boutin; Louise Binder; Linda Wilhelm
Journal:  Clin Pharmacol Ther       Date:  2019-01-04       Impact factor: 6.875

2.  From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.

Authors:  H-G Eichler; L G Baird; R Barker; B Bloechl-Daum; F Børlum-Kristensen; J Brown; R Chua; S Del Signore; U Dugan; J Ferguson; S Garner; W Goettsch; J Haigh; P Honig; A Hoos; P Huckle; T Kondo; Y Le Cam; H Leufkens; R Lim; C Longson; M Lumpkin; J Maraganore; B O'Rourke; K Oye; E Pezalla; F Pignatti; J Raine; G Rasi; T Salmonson; D Samaha; S Schneeweiss; P D Siviero; M Skinner; J R Teagarden; T Tominaga; M R Trusheim; S Tunis; T F Unger; S Vamvakas; G Hirsch
Journal:  Clin Pharmacol Ther       Date:  2015-02-04       Impact factor: 6.875

Review 3.  Approaches to attenuated psychosis syndrome treatments: A perspective on the regulatory issues.

Authors:  Luca Pani; Richard S E Keefe
Journal:  Schizophr Res Cogn       Date:  2019-06-14

4.  Number of patients studied prior to approval of new medicines: a database analysis.

Authors:  Ruben G Duijnhoven; Sabine M J M Straus; June M Raine; Anthonius de Boer; Arno W Hoes; Marie L De Bruin
Journal:  PLoS Med       Date:  2013-03-19       Impact factor: 11.069

5.  Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014.

Authors:  Anthony J Hatswell; Gianluca Baio; Jesse A Berlin; Alar Irs; Nick Freemantle
Journal:  BMJ Open       Date:  2016-06-30       Impact factor: 2.692

6.  Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

Authors:  G Hirsch; M Trusheim; E Cobbs; M Bala; S Garner; D Hartman; K Isaacs; M Lumpkin; R Lim; K Oye; E Pezalla; P Saltonstall; H Selker
Journal:  Clin Pharmacol Ther       Date:  2016-10-22       Impact factor: 6.875
  6 in total

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