History of Orphan Drug Regulation—United States and Beyond

Clinical Pharmacology and Therapeutics

Volumn , Issue , 2016, Pages 342-343

  Haffner, M E ^a  

^a Haffner Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ERYTHROPOIETIN; ORPHAN DRUG;

ACT; DRUG INDUSTRY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LAW; NOTE; PRIORITY JOURNAL; RARE DISEASE; UNITED STATES; US ORPHAN DRUG ACT;

EID: 84986581698     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.426     Document Type: Note

References (2)

1. Greene, J.A. & Podolsky, S.H. Reform, regulation, and pharmaceuticals — the Kefauver-Harris Amendments at 50. N. Engl. J. Med. 367, 1481–1483 (2012).
2. Finkel, M.J. Drugs of limited commercial value. N. Engl. J. Med. 302, 643–644 (1980).