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EMA: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

04.07.2013
The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above. For ...

EMA: Draft guideline on adjustment for baseline covariate

04.07.2013
The note for guidance on statistical principles for clinical trials (ICH E9) briefly addresses the problem of adjustment for covariates. It advises experimenters ‘to identify the covariates ...

GMP: Guideline on the European Drug Master File Procedure updated

27.06.2013
The \"Guideline on Active Substance Master File Procedure\" which was developed by EMA\'s Quality Woring Party, describes the procedure that can be used to document an API\'s quality for a ...

GMP: WHO Guideline on Quality Risk Management finalised

27.06.2013
Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. The aim of this guideline is to assist the implementation of a QRM system, ...

GMP: GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

27.06.2013
The European Medicines Agency EMA specifies in one of its questions and answers documents on the GMP guideline under the heading \"EU GMP guide part II: Basic requirements for active substances ...

FDA: Draft Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics

27.06.2013
The provisions of this guidance, when finalized, will replace the current guidance for industry entitled Fast Track Drug Development Programs Designation, Development, and Application Review ...

FDA: Draft Guidance for Industry Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic

27.06.2013
This guidance, when finalized, will supersede the guidance entitled “Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic ...

EMA: Guideline on quality of biological active substances produced by transgene expression in animals

13.06.2013
The principal aim of this guideline is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal ...

EMA: Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measure

13.06.2013
The aim of this position paper is to raise awareness for this issue, provide insight with regards to how the benefit-risk assessment of such products might be impacted and to discuss in general ...

EMA: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

13.06.2013
The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the ...