EMA/EC consultations 2014

• Submission of comments on 'Questions and Answers on Benzyl alcohol in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use’ get_app
• Submission of comments on 'Questions and Answers on Ethanol in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use’ get_app
• Submission of comments on 'Questions and Answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use’ get_app
• Submission of comments on 'Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies’ get_app
• Submission of comments on 'Draft reflection paper on the wording of indication for medicinal products for treatment of type 2 diabetes’ get_app
• Submission of comments on 'Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)’ get_app
• Submission of comments on 'Reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products’ get_app
• Submission of comments on 'Concept paper on review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products’ get_app
• Submission of comments on the EMA/CHMP/CVMP/QWP Concept paper on the need for a single note for guidance on the chemistry of active substances get_app
• Submission of comments on 'Concept paper on good genomics biomarker practices’ get_app
• Submission of comments on the Concept Paper on the establishment of a guideline on the selection of sterilisation processes for drug products’ get_app
• Submission of comments on 'Draft paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease’ get_app
• Submission of comments on 'Draft European Union individual case safety report (ICSR) implementation guide’ get_app
• Submission of comments on Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency get_app
• Submission of comments on 'Draft reflection paper on the wording of indication for medicinal products for treatment of type 2 diabetes’ get_app
• Submission of comments on 'Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches’ get_app
• Submission of comments on 'Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency’ get_app
• Submission of comments on 'Draft guideline on the investigation of subgroups in confirmatory clinical trials' get_app
• Submission of comments on 'Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis’ get_app
• Submission of comments on 'Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies’ get_app
• Submission of comments on 'Draft guideline on non-clinical local tolerance testing of medicinal products’ get_app
• Submission of comments on 'Questions and Answers on Benzoic acid and Benzoates in the context of the revision of the guideline on Excipients in the label and package leaflet of medicinal products for human use’ get_app