Tag Archive
The following is a list of all entries tagged with Drug Evaluation:
Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus
Filed in clinical, February 26, 2010, 11:33 amDiabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus
Filed in clinical, February 25, 2010, 11:33 amThe current CHMP Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus CPMP/EWP/1080/00 was adopted by the CHMP in November 2002. New aspects have emerged since then including:
Drug Regulators Publish Concept Paper on the Need to Revise Clinical Guidance for Depression
Filed in EMEA,clinical,regulatory, November 11, 2009, 3:48 pmMajor Depressive Disorder (MDD) is one of the most common psychiatric disorders, which is the fourth leading cause of global disease burden and affects about 15 % of the general population. As outlined in the guidance document MDD is not a benign disorder and risk of suicide is considerable.
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