An open science pathway for drug marketing authorization-Registered drug approval

Florian Naudet; Maximilian Siebert; Rémy Boussageon; Ioana A Cristea; Erick H Turner

doi:10.1371/journal.pmed.1003726

An open science pathway for drug marketing authorization-Registered drug approval

PLoS Med. 2021 Aug 9;18(8):e1003726. doi: 10.1371/journal.pmed.1003726. eCollection 2021 Aug.

Authors

Florian Naudet¹, Maximilian Siebert¹, Rémy Boussageon², Ioana A Cristea^{3

4}, Erick H Turner^{5

6}

Affiliations

¹ Université de Rennes 1, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Rennes, France.
² Université Claude Bernard Lyon 1, CNRS, UMR 5558, LBBE, EMET, Lyon, France.
³ Department of Brain and Behavioral Sciences, University of Pavia, Italy.
⁴ IRCCS Mondino Foundation, Pavia, Italy.
⁵ Behavioral Health and Neurosciences Division, VA Portland Health Care System, Portland, Oregon, United States of America.
⁶ Department of Psychiatry, Oregon Health & Science University, Portland, Oregon, United States of America.

Abstract

Florian Naudet and co-authors propose a pathway involving registered criteria for evaluation and approval of new drugs.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Drug Approval / methods*
Drug Approval / organization & administration
European Union*
Marketing
Pharmaceutical Preparations

Substances

Pharmaceutical Preparations

Grants and funding

This essay was submitted to the Reimagine Biomedical Research for a Healthier Future Essay Challenge sponsored by the Health Research Alliance and PLOS. It has been recommended for publication in PLOS Medicine. The authors will be receiving a $5,000 prize from the Health Research Alliance. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.