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FDA: Draft guidance - Pulmonary Tuberculosis: Developing Drugs for Treatment

14.11.2013
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. Specifically, this guidance addresses the FDA’s current ...

FDA: Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

26.09.2013
Due to the increasing interest and activity in the development of CGT products and because of their potential to address unmet medical needs the FDA published this draft guidance. It is intended ...

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

20.09.2013
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects ...

FDA: Electronic Source Data in Clinical Investigations

20.09.2013
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source ...

EMA: Draft policy 70: Publication and access to clinical-trial data

05.09.2013
There is growing demand from external stakeholders for full transparency, not only about the European Medicines Agency\'s deliberations and actions, but also about the data and results from ...

EMA: Guidance on triggers for inspections of bioequivalence trials

29.08.2013
This document represents a non-exhaustive overview of issues which are taken into account during the assessment phase. Identification of other triggers not mentioned in this document is possible. ...

EMA: Guideline on pharmaceutical development of medicines for paediatric use

08.08.2013
The “Paediatric Regulation” aims to facilitate the development and accessibility of age-appropriate paediatric medicines. This aim should be achieved without subjecting children to unnecessary ...

FDA: Draft Guidance - Considerations for the Design of Early - Phase Clinical Trials of Cellular and Gene Therapy Products

11.07.2013
This guidance provides recommendations to assist in designing early-phase clinical trials of CGT products. When this guidance is finalized, we believe it will clarify OCTGT’s current ...

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 ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

06.06.2013
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...