Orphan medicinal products: A challenge from an industry point of view?

Pharmaceuticals Policy and Law

Volumn 3, Issue , 2001, Pages 47-54

  Cabri, Patrick ^a   Tambuyzer, Erik T ^a  

^a Genzyme Corporation   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85013587460     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of December 16,1999 on orphan medicinal products, Official Journal of the European Communities, 22.1.2000, L18/1-5.
2. Orphan Drug Regulations, Food and Drug Administration, Code of Federal Regulations, Title 21, (Vol. 5), Parts 300-499, Revised as of April 1, 1998.
3. L.A. Kent and E.T. Tambuyzer, Partnerships between patients, medicine and the biotechnology industry, Nature Biotechnology 17 (October 1999), 935.
4. E.T. Tambuyzer, The European Orphan Medicinal Products Regulation and the Biotechnology-based Industry in Europe, Journal of Commercial Biotechnology 6(4) (Spring 2000), 340-344.
5. R.A. Bohrer and J.T. Prince, A tale of two Proteins: The FDA’s uncertain interpretation of the orphan drug act, Harvard Journal of Law and Technology 12(2) (Winter 1999).
6. S.R. Shulman and M.Mannochia, The US Orphan Drug Programme 1983-1995, Pharmacoeconomics 12(3) (1997), 312-325.