Challenges and Opportunities in Rare Disease Drug Development

Author:

Smith BP1

Affiliation:

1. Novartis Institutes of Biomedical Research, Inc.; Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference11 articles.

1. Globalgenes.org https://globalgenes.org/rare-diseases-facts-statistics/ 2016

2. Maisel , Y. A star is born: famous faces of rare disease - Progeria, Parkinson's, ALS, MS, SCID & more Primary-immunodeficiency.com http://www.primary-immunodeficiency.com/blog/a-star-is-born-famous-faces-of-rare-disease-fprogeria-parkinsons-als-ms-scid-more 2014

3. History of orphan drug regulation ---United States and beyond;Haffner;Clin. Pharmacol. Ther.,2016

4. US Food and Drug Administration Rare diseases: common issues in drug development guidance for industry 2015 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458485.pdf

5. Drugs against rare diseases: are the regulatory standards higher?;Gobburu;Clin. Pharmacol. Ther.,2016

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