FDA: Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring

At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments have been ...

EMA: This paper highlight s issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration

This paper highlights issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration. ...

GMP: Frequently asked GMP Question: How to reduce testing and comply with GMP?

Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the ...

GMP: Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

The guideline is supposed to define uniform requirements for the \"life cycle management\" of contract laboratories. In addition the APIC had already prepared a guideline for the management of ...

GMP: What\'s new from the FDA regarding Medical Devices?

In hardly any other area the FDA ‘s Center for Devices and Radiological Health publishes so many guidelines as in the area of medical devices. This is a consequence of the wide range of medical ...

GMP: New EMA Guideline on Starting Materials from Biological Medicinal Products

The Guideline describes the requirements for the quality documentation of module 3 of the marketing authorisation dossier. Here, the complete manufacturing process including all sources as well as ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

This document replaces and updates the previous points to consider on amyotrophic lateral sclerosis and focuses on the design of studies for disease-modifying as well as symptomatic treatments in ...

EMA: Concept paper on the development of product-specific guidance on demonstration of bioequivalence

This document describes for specific products the regulatory view on specific aspects related to the demonstration of bioequivalence based on previous assessments of generic medicines. ...

EMA: Guideline on pharmaceutical development of medicines for paediatric use

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 ...

EMA: Reflection paper on management of clinical risks deriving from insertional mutagenesis

This reflection paper is aimed at discussing the factors contributing to genotoxicity of vector integration, the strategies to reduce the risk associated to insertional mutagenesis and the assays ...

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