水曜日, 10月 11, 0018

CHMP new guidance, concept paper

06/10/06
Guideline on Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome
Overview of Comments on Draft Guideline on Clinical investigation of Medicinal Products in Prevention and Treatment Acute Respiratory Distress Syndrome

Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population
Overview of Comments on the Draft Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population

Concept Paper on the Development of a Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder

Concept Paper on the Need for Regulatory Gudiance in the Evaluation of Medicinal Products for a First-Line Indication of Fixed Combination Medicinal Products in Therapeutic Doses in the Treatment of Hypertension

Concept Paper on the Need for Revision of the Note of Guidance on Antiarrhythmics

水曜日, 10月 04, 0018

CHMP Formulations of Choice for the Paediatric Population

02/10/06
Paediatric Working Party (PEG) Workprogramme 2007 Reflection Paper: Formulations of Choice for the Paediatric PopulationOverview of comments received on Draft Reflection Paper: Formulations of Choice for the Paediatric Population