Engaging patients in medicines regulation: a tale of two agencies

The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experi...

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Veröffentlicht in:Nature reviews. Drug discovery 2019-11, Vol.18 (12), p.885-886
Hauptverfasser: Mavris, Maria, Furia Helms, Andrea, Bere, Nathalie
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container_title Nature reviews. Drug discovery
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creator Mavris, Maria
Furia Helms, Andrea
Bere, Nathalie
description The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experience between the agencies and some impacts on patient engagement. The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experience between the agencies and some impacts on patient engagement.
doi_str_mv 10.1038/d41573-019-00164-y
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source MEDLINE; Nature; Springer Nature - Complete Springer Journals
subjects Caregivers
Clinical trials
Collaboration
Comment
Committees
Consumers
Decision making
Drug Approval - legislation & jurisprudence
Drugs
European Union
Government Agencies - legislation & jurisprudence
Humans
Laws, regulations and rules
Medicine
Patient Participation
Patients
Pharmacovigilance
Prescription Drugs - standards
Product development
Public hearings
Regulatory approval
United States
United States Food and Drug Administration
title Engaging patients in medicines regulation: a tale of two agencies
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