CPMP note for guidance: clinical trials on the medicinal products in the treatment of cardiac failure.

Draft Guideline on clinical investigation of medicinal products for the treatment of acute heart failure (CHMP/EWP/2986/03 Rev 1)

7 This guideline replaces addendum CPMP/EWP/2986/03 " Note for guidance on clinical investigation of 8 medicinal products for the treatment of cardiac failure – addendum on acute cardiac failure ". 9 10 Comments should be provided using this template. The completed comments form should be sent to [email protected] 11 Keywords Acute heart failure, acute decompensated heart failure, ...

Committee for Proprietary Medicinal Products (cpmp) Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Hypertension

Medicinal Products in the Treatment of Chronic Peripheral Arterial Occlusive Disease

Status Last revised 1995 Previous titles/other references Clinical Investigation of Drugs for the Treatment of Chronic Peripheral Arterial Diseases, III/5936/94, CPMP/233/95 Additional Notes This note for guidance is intended to provide guidance for the evaluation of medicinal products in the treatment of chronic peripheral arterial occlusive disease. It should be read in conjunction with Part ...

Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

This guideline replaces the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03)’. Rev. 1 and Rev. 2 were combined: Rev. 1 was regarding imaging surrogate endpoints Rev. 2 was regarding the need for outcome studies based on safety data at the time of Marketing Authorisation Application.

Draft Guideline on Clinical Investigation of Medicial Products in the Treatment of Diabetes Mellitus

Discussion in the Efficacy Working Party June 2000 – May 2001 Transmission to CPMP July 2001 Release for consultation July 2001 Deadline for comments January 2002 Discussion in the Efficacy Working Party April 2002 Transmission to CPMP May 2002 Adoption by CPMP May 2002 Date for coming into operation November 2002 Draft Rev. 1 agreed by Efficacy Working Party January 2010 Adoption by CHMP for r...