Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval-Reference-Cited by-同舟云学术

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

Published:2019-12-16 Issue:1 Volume:86 Page:170-174
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Joppi Roberta¹²^ORCID,Bertele Vittorio¹^ORCID,Vannini Tommaso³,Garattini Silvio¹,Banzi Rita¹

Affiliation:

1. Centre for Health Regulatory PoliciesIstituto di Ricerche Farmacologiche Mario Negri IRCSS Milan Italy

2. Clinical Research and Drug Assessment UnitAzienda Ulss 9 Scaligera di Verona Verona Italy

3. Cardiovascular Department, Laboratory of Cardiovascular PreventionIstituto di Ricerche Farmacologiche Mario Negri IRCSS Milan Italy

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14130

Reference16 articles.

1. US Food and Drug Administration.Guidance for industry: expedited programs for serious conditions—drugs and biologics.https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf) Accessed March 14 2019

2. The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

3. Are drug regulators really too slow?;Marciniak TA;BMJ,2017

4. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

5. Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015

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