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New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies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

EMA: Clinical Trial Regulation

30.04.2015
The Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants. On ...

EMA: Preventing medication errors in the European Union

30.04.2015
The European Medicines Agency (EMA), on behalf of the European Union (EU) Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and ...

GMP: Counterfeiting in Reimport of Viread in the legal Supply Chain

30.04.2015
Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet, ...

RAPS: FDA Finalizes Lot Distribution Report Guidance With Few Changes

30.04.2015
New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called \"lot distribution reports\" (LDRs)—reports ...

EMA: Codeine not to be used in children below 12 years for cough and cold

30.04.2015
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing ...