Literature DB >> 27041795

The hazards of rapid approval of new drugs.

Jennifer Martin1, Gillian Shenfield2.   

Abstract

Keywords:  Therapeutic Goods Administration; drug approval; drug regulation

Year:  2016        PMID： 27041795      PMCID： PMC4816872          DOI： 10.18773/austprescr.2016.005

Source DB:  PubMed          Journal:  Aust Prescr        ISSN： 0312-8008


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  7 in total

1.  Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.

Authors:  Joel Lexchin
Journal:  Br J Clin Pharmacol       Date:  2015-05       Impact factor: 4.335

2.  Reevaluating the accelerated approval process for oncology drugs.

Authors:  Wyndham H Wilson; David P Schenkein; Cheryl L Jernigan; Janet Woodcock; Richard L Schilsky
Journal:  Clin Cancer Res       Date:  2013-04-03       Impact factor: 12.531

3.  Troglitazone-induced liver failure: a case study.

Authors:  David J Graham; Lanh Green; John R Senior; Parivash Nourjah
Journal:  Am J Med       Date:  2003-03       Impact factor: 4.965

4.  Dabigatran: how the drug company withheld important analyses.

Authors:  Deborah Cohen
Journal:  BMJ       Date:  2014-07-23

5.  Dabigatran, bleeding, and the regulators.

Authors:  Thomas J Moore; Michael R Cohen; Donald R Mattison
Journal:  BMJ       Date:  2014-07-23

6.  The accelerated approval of oncologic drugs: lessons from ponatinib.

Authors:  Vinay Prasad; Sham Mailankody
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

7.  A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias.

Authors:  J E Cortes; D-W Kim; J Pinilla-Ibarz; P le Coutre; R Paquette; C Chuah; F E Nicolini; J F Apperley; H J Khoury; M Talpaz; J DiPersio; D J DeAngelo; E Abruzzese; D Rea; M Baccarani; M C Müller; C Gambacorti-Passerini; S Wong; S Lustgarten; V M Rivera; T Clackson; C D Turner; F G Haluska; F Guilhot; M W Deininger; A Hochhaus; T Hughes; J M Goldman; N P Shah; H Kantarjian
Journal:  N Engl J Med       Date:  2013-11-01       Impact factor: 91.245
  7 in total
  4 in total

1.  Fast-tracking of new drugs: getting the balance right.

Authors:  Paul Kubler
Journal:  Aust Prescr       Date:  2018-08-01

Review 2.  Pharmacovigilance and expedited drug approvals.

Authors:  Matthew Linger; Jennifer Martin
Journal:  Aust Prescr       Date:  2018-04-03

3.  Fast-track pathways for drug approvals: the Australian experience so far.

Authors:  Adrian Bootes; Josephine Maundu; Sarah Golding; Mark McDonald; John Lombard
Journal:  Aust Prescr       Date:  2019-08-01

4.  Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey.

Authors:  Ran D Goldman; Shashidhar R Marneni; Michelle Seiler; Julie C Brown; Eileen J Klein; Cristina Parra Cotanda; Renana Gelernter; Tyler D Yan; Julia Hoeffe; Adrienne L Davis; Mark A Griffiths; Jeanine E Hall; Gianluca Gualco; Ahmed Mater; Sergio Manzano; Graham C Thompson; Sara Ahmed; Samina Ali; Naoki Shimizu
Journal:  Clin Ther       Date:  2020-10-03       Impact factor: 3.393
  4 in total

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