Aktualności
RAPS: Bioethics Council Calls for Reforms for Clinical Trials Involving Children
28.05.2015
The Nuffield Council on Bioethics has released a report on the ethical issues surrounding clinical research involving children in the UK and EU. The report, which looks at the current status of
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EFSA: Endocrine active substances and non-monotonic dose response – EFSA’s ongoing work
28.05.2015
EFSA is currently involved in a number of initiatives to develop scientific knowledge in the field of endocrine active substances and also on overlapping issues such as non-monotonic dose-response
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of May 26, 2015 concerning the suspension of marketing authorizations for medicinal products because of wrongly studies by GVK Biosc
28.05.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of May 26, 2015 concerning the suspension of marketing
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EMA: Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products
21.05.2015
This guideline defines scientific principles and provides guidance for the development and evaluation of gene therapy medicinal products (GTMP) intended for use in humans and presented for
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RAPS: FDA to Study Effect of Generic Drug Appearance on Patient Adherence
21.05.2015
Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. FDA has long been
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EMA: Draft guideline on clinical development of fixed combination medicinal products
21.05.2015
This guideline addresses the clinical development requirements of fixed combination medicinal products, which shall reflect their intended therapeutic use and indication. It replaces the guideline
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GMP: FDA finalizes Guidelines for Biosimilars
21.05.2015
In February 2009, the US Food and Drug Administration has published three draft guidance documents on the development of biosimilars. Now, on 15 April, the FDA issued the finalized version of
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GMP: India\'s Track&Trace System for the Export of Medicinal Products
21.05.2015
On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace
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RAPS: FDA Legislation Tracker
14.05.2015
Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary
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EMA: Risk minimisation strategy for high strength and fixed combination insulin products
14.05.2015
The guidance provides a strategy to minimise the potential risk of medication errors associated with the introduction of high strength insulins (i.e. higher than the EU-wide standard of 100
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