金曜日, 8月 07, 0021

20090806 EMEA: Concept paper: Update for lipid lowering and antihypertensive guidance

http://www.emea.europa.eu/pdfs/human/ewp/35049509en.pdf

06/08/09 Concept paper on the Need to update the Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03) and the Note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (CPMP/EWP/238/95 rev. 2) to discuss the need for outcome studies basis on safety data at the time of MAA

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