20080305 EMEA new concept paers and guidelines

05/03/08
Draft Guideline on Fixed Combination Medicinal Products Rev. 1
Human Medicines
Human Guidelines - Clinical Efficacy and Safety
05/03/08
Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-operative Venous Thromboembolic Risk Rev. 1 Corr
Human Medicines
Human Guidelines - Clinical Efficacy and Safety
05/03/08
Guideline on the development of new medicinal products for the treatment of ulcerative colitis See also: Overview of Comments received on the draft guideline
Human Medicines
Human Guidelines - Clinical Efficacy and Safety
05/03/08
Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications
Human Medicines
Human Guidelines - Non-Clinical
05/03/08
Guideline on the Non-Clinical Development of Fixed Combinations of Medicinal Products
Human Medicines
Human Guidelines - Non-Clinical
05/03/08
Draft Guideline on the non-clinical guideline on drug-induced hepatotoxicity
Human Medicines
Human Guidelines - Non-Clinical
05/03/08
Concept paper on the need for revision of the Note for Guidance on photosafety testing (CPMP/SWP/398/01)
Human Medicines
Human Guidelines - Non-Clinical
04/03/08
Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality documentation concerning Biological Investigational Medicinal Products in Clinical Trials
Human Medicines
Human Guidelines - Biologicals