What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?

Author:

Price John

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference80 articles.

1. US Food and Drug Administration, Orphan Drug Act—Relevant Excerpts: fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm364750.htm. Accessed 05.09.16.

2. European Medicines Agency, Orphan designation: ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp&mid=WC0b01ac05800240ce. Accessed 05.9.16.

3. Physician and patient perceptions regarding physician training in rare diseases: the need for stronger educational initiatives for physicians;Engel;J Rare Dis,2013

4. The Rare Diseases Act 2002: www.congress.gov/107/plaws/publ280/PLAW-107publ280.pdf. Accessed 25.09.16.

5. A new initiative on precision medicine;Collins;N Engl J Med,2015

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