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Orphanet Journal of Rare Diseases
Published in: Orphanet Journal of Rare Diseases 2/2012

Open Access 01-11-2012 | Meeting abstract

Leveraging existing opportunities for improved Orphan Drug approval in the EU

Author: Catarina Edfjäll

Published in: Orphanet Journal of Rare Diseases | Special Issue 2/2012

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Excerpt

The EU regulatory framework provides opportunities for increased flexibility and speed for Orphan Medicinal Product (OMP) marketing authorisations. Nevertheless the yearly rate of OMP approvals is not increasing [1] and available tools and procedures are used infrequently. …
Literature
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2.
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS: Regulatory Review of Novel Therapeutics – comparison of three regulatory agencies. N. Engl. J. Med. 2012, 366: 2284-2293. 10.1056/NEJMsa1200223.PubMedCentralCrossRefPubMed
3.
Pariser AR, Slack DJ, Bauer LJ, Warner CA, Tracy LA: Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010. Drug Discovery Today. 2012, 17: 898-904. 10.1016/j.drudis.2012.04.011.CrossRefPubMed
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Metadata
Title
Leveraging existing opportunities for improved Orphan Drug approval in the EU
Author
Catarina Edfjäll
Publication date
01-11-2012
Publisher
BioMed Central
Published in
Orphanet Journal of Rare Diseases / Issue Special Issue 2/2012
Electronic ISSN: 1750-1172
DOI
https://doi.org/10.1186/1750-1172-7-S2-A27

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