Special FDA designations for drug development : orphan, fast track, accelerated approval, priority review, and breakthrough therapy

Daniel Tobias Michaeli, Thomas Michaeli, Sebastian Albers, Tobias Boch, Julia Caroline Michaeli

Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.

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Year of publication:	2024
Authors:	Michaeli, Daniel ; Michaeli, Christoph T. ; Albers, Sebastian ; Boch, Tobias ; Michaeli, Julia
Published in:	The European journal of health economics. - Berlin : Springer, ISSN 1618-7601, ZDB-ID 2011428-X. - Vol. 25.2024, 6, p. 979-997
Subject:	Accelerated approval \| Breakthrough therapy \| Clinical trial \| Drug development \| Drug price \| Efficacy \| European medicines agency \| Fast track \| Healthcare policy \| Innovation \| Orphan designation \| Pharmaceutical policy \| Priority review \| Safety \| Special designation \| US food and drug administration \| Arzneimittel \| Pharmaceuticals \| Pharmaindustrie \| Pharmaceutical industry \| Pharmakologie \| Pharmacology \| USA \| United States \| Arzneimittelrecht \| Pharmaceutical law \| Arzneimittelmarkt \| Pharmaceutical market \| Medizinische Behandlung \| Medical treatment \| Gesundheitspolitik \| Health policy \| Produktentwicklung \| New product development \| EU-Staaten \| EU countries \| Gesundheitswesen \| Health care system

Extent:	Illustrationen
Type of publication:	Article
Type of publication (narrower categories):	Aufsatz in Zeitschrift ; Article in journal
Language:	English
Notes:	Online veröffentlicht: 14. November 2023 Gesehen am 05.03.2024
Other identifiers:	10.1007/s10198-023-01639-x [DOI]
Source:	ECONIS - Online Catalogue of the ZBW

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