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RAPS: EMA Says Companies Still Need to Report Side Effects of Donated Drugs

14.05.2015
Drug makers are frequently involved in relief and humanitarian aid efforts, often through donating their products. However, in light of recent outbreaks of neglected tropical diseases such as ...

EMA: Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

14.05.2015
This reflection paper is intended to reflect the current experience of the Quality Working Party (QWP), of the Committee for Medicinal Products for Human Use (CHMP) and the Co-ordination Group for ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of May 04, 2015 concerning the avoidance of prescribing certain drugs including hepatitis C and amiodarone

14.05.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of May 04, 2015 concerning the avoidance of prescribing ...

URPL: The report on the activities of the European Medicines Agency (EMA) in 2014

14.05.2015
This document inludes information about the report on the activities of the European Medicines Agency (EMA) in 2014. ...

FDA: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

07.05.2015
This guidance describes the Agency’s current thinking on factors to consider when demonstrating that a proposed therapeutic protein product (hereinafter proposed product or proposed biosimilar ...

FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

07.05.2015
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (hereinafter proposed product2) is biosimilar to a reference product for purposes of the ...

EMA: EMA recommends avoidance of certain hepatitis C medicines and amiodarone together

07.05.2015
Concomitant use may increase risk of slow heart rate and related problems. The European Medicines Agency (EMA) has confirmed a risk of severe bradycardia (slow heart rate) or heart block (problems ...

EMA: Progress in science, medicines, health

07.05.2015
The annual report published by the European Medicines Agency (EMA) today focuses on the Agency’s key priorities, including the evaluation of medicines and the support to research and development ...

RAPS: FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

07.05.2015
New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided ...

RAPS: FDA Says Chinese API Manufacturer Falsified Drug Data

07.05.2015
The US Food and Drug Administration (FDA) has sent a Warning Letter to a Chinese active pharmaceutical ingredient (API) manufacturer after finding that the firm did not exercise proper control ...

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