Rare diseases and medical devices in the european union

Pharmaceuticals Policy and Law

Volumn 3, Issue , 2001, Pages 69-78

  Casteels Rappagliosi, Brigitte ^a  

^a NONE   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85013610717     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Decision No 1295/188/EC of the European Parliament and the Council of 29 April 1999; Programme of Community Action on rare diseases (1999-2003), O.J. n° L 155 of 22.06.1999).
2. Regulation (EC) No 141/2000 of the European Parliament and the Council of 12 December 1999 on Orphan Medicinal Products, O.J. n° L 18 of 22.01.00.
3. Dr Eric Tambuyzer, The European Orphan Medicinal Products Regulation and the Biotechnologybased industry in Europe, Journal of Commercial Biotechnology 6 (2000).
4. Council Directive (93/42/EEC) of 14 June 1993 concerning Medical Devices, O.J. No L 169 of 12.07.1993.
5. Council Directive (90/385/EEC)of 20 June 1990 on the approximation of the laws of the Member States relating to Active Implantable Medical Devices, O.J. No L 189 of 20.07.1993.
6. Directive (98/79/EEC) of the European Parliament and the Council of 27 October 1998 on in In Vitro Diagnostic Medical Devices, O.J. No L 331 of 07.12.1998.
7. The US Orphan Drug Act, 4 January 1983.
8. The Orphan Drug Act and its Implementation, A program overview.
9. Department of Heath and Human Services, FDA - Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for applications, Federal Register 65(153) (8 August 2000).
10. Grant Awards, List of current and prior year grant award recipients, FDA.
11. Humanitarian Use Devices Regulations, 26 June 1996.
12. Summary of Humanitarian Use Device (HUD) legislation, FDA, 1996.
13. EUCOMED, Industry profile, 2000.