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FDA: Guidance for industry – dosage and administration section of labeling for human prescription drug and biological products

08.04.2010
The goal of this guidance is to help ensure that the dosage and administration section contains all the information needed for safe and effective dosing and administration of a drug and the ...

EMA: European Medicines Agency standard operating procedure (SOPs) on: Type IA variations to centralised marketing authorisations (medcines for human use)

08.04.2010
The purpose of this SOP is to describe the procedure for handling of Type IA variations to centrally authorized medicinal product for human use. It applies to the Quality of Medicines and Safety ...

EMA: Guideline on the Evaluation of Medicinal Products indicated for treatment of bacterial infections

08.04.2010
This guideline considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents and the layout and wording of some ...

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

08.04.2010
The purpose of this guideline is to provide applicants and regulators with harmonized guidance for applications for marketing authorization for IVIg. ...

EMA: Updated inventory of herbal substances for assessment

08.04.2010
Inventory of herbal substances for assessment – alphabetical order. ...

EMA: Compilation of Community Procedures on Inspections and Exchange of Information

08.04.2010
The Compilation of Procedures is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative ...

Best Practice Guide for the Decentralised and Mutual Recognition Procedures

08.04.2010
Competent authorities should ensure that their assessment reports are written according to the CMD guideline on the assessment report for Mutual Recognition and Decentralised Procedure and the ...

CMD(h) Standard Operating Procedure Disagreement in procedures – Referral to CMD(h)

18.03.2010
Procedure to be followed to the discussion in CMD(h) in case of disagreement between member states in particular mutual recognition or decentralised procedure. ...

EMEA: Experience of the CHMP Peer Review – A tool for quality assurance of the evaluation of new marketing authorization application in the Centralised Procedure.

18.03.2010
The CHMP Peer Review process applies to the initial phase of the assessment of new Marketing Authorisation Application. It is a process by which other members of the CHMP review Rapporteurs’ ...