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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of June 2, 2015 concerning the position of Coordination Group for the Mutual Recognition and Decentralised safety of medicinal produ

11.06.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of June 2, 2015 concerning the position of Coordination Group ...

FDA: ANDA Submissions – Refuse-to-Receive Standards

28.05.2015
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is ...

FDA: M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

28.05.2015
The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, ...

EMA: EMA recommends treatment for rare cancer in children

28.05.2015
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma, a type of cancer that most often ...

EMA: First medicine for rare blood cancer

28.05.2015
The European Medicines Agency (EMA) has recommended extending the use of Imbruvica (ibrutinib) to include the treatment of patients with Waldenstrӧm’s macroglobulinaemia, a rare blood cell ...

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 ...

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 ...

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 ...

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 ...

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 ...