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Polish Ministry of Health: Project of the Act related to reimbrusment of medicinal products, Foods for particular nutritional uses and medical devices

19.10.2010
Project of the Act related to reimbrusment of medicinal products, Foods for particular nutritional uses and medical devices ...

EMA: Scientific guideline: ICH guideline E2F: Note for guidance on development safety update reports: Step 4

19.10.2010
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are ...

EMA: Scientific guideline: Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants), draft: consultation open

19.10.2010
This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type. ...

EMA: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

19.10.2010
Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures, ec: Scientific advice, Extension of marketing authorisations, ...

EMA: Regulatory and procedural guideline: Post-authorisation procedural advice: Human medicinal products

19.10.2010
This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

EMA: Explanatory note on fees payable to the European Medicines Agency

19.10.2010
Following the publication of the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures1 as last adopted by the Agency’s ...

FDA: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND

19.10.2010
This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new drug ...

EMA: Scientific guideline: ICH guideline E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 4

11.10.2010
The guideline describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15). Qualification is a ...

EMA: Scientific guideline: ICH guideline E2F : Note for guidance on development safety update report - Step 4

11.10.2010
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are ...

FDA: Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies

11.10.2010
This document provides guidance to sponsors and investigators on safety reporting requirements for human drug and biological products2 that are being investigated under an investigational new drug ...