Ethics/Regulatory

EMA to offer advice for new biosimilars

Tuesday, December 20, 2016

The EMA will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

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Commonwealth Informatics, FDA sign consultation agreement

Thursday, December 15, 2016

Commonwealth Informatics, a provider of clinical and safety analytics products and services, signed a new contract to support the use of advanced drug safety review tools at the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The focus of the agreement is for Commonwealth to support the expansion of the use of the analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance.

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Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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