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REFERENCES

  • 1
    The European Agency for the Evaluation of Medicinal Products. Frequently asked questions. URL: http://www.emea.eu.int/pdfs/general/direct/faqs/FAQen.pdf.
  • 2
    US Food and Drug Administration. Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Technologies. URL: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
  • 3
    Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union 30.4.2004.
  • 4
    Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. URL: www.emea.eu.int.
  • 5
    The European Medicines Agency. Tenth annual report of the European Medicines Agency. URL: http://www.emea.eu.int/pdfs/general/direct/emeaar/ar6149205en.pdf.
  • 6
    Guideline on Summary of product characteristics (The rules governing medicinal products in the European Union, The Notice to Applicants). URL: http://pharmacos.eudra.org/F2/eudralex/vol-2/c/spcGuidRev1-Oct2005.pdf.
  • 7
    Van Zwieten-Boot B. Preparation of guidelines for testing and evaluating new drugs in several therapeutic areas [newsletter]. Eur Soc Clin Phar 1999; 92: 23.
  • 8
    Hirschfeld S, Pazdur R. Oncology drug development: United States Food and Drug Administration perspective. Crit Rev Oncol Hemat 2002; 42: 13743.