1. Advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218493.pdf
2. European Medicines Agency ICH harmonised tripartite guideline E6: note for guidance on good clinical practice (PMP/ICH/135/95)
3. European Commission Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
4. European Commission Communication from the commission-detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘ENTR/CT 3’)
5. International conference of harmonization of technical requirements for registration of pharmaceuticals for human use Step 4