Europe -
Application of EU Clinical Trial Regulation Delayed to 2019

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

"Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday.

The agency says it will provide an update at the next meeting of the Management Board in October 2017, following closer work with its IT service provider to ensure corrective measures are implemented...

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USA -
Sclérose en plaques : une enquête sur les prix met sous pression sept labos, dont Sanofi

Les prix des traitements contre la sclérose en plaque ont été multiplié par cinq depuis 2004 aux États-Unis. Deux membres de la Chambre des Représentants ont lancé une enquête pour déterminer la raison de telles hausses...

Australia -
Pharmacovigilance Inspection Program: information sessions

The Therapeutic Goods Administration (TGA) invites up to two pharmacovigilance personnel from your organisation to attend a face-to-face information session about the TGA Pharmacovigilance Inspection Program (PVIP). Each session will cover the pharmacovigilance guidelines, preparing for inspections, inspection process, and close out of inspections and participants will have an opportunity to ask questions about the program. Sessions will be held in Sydney, Melbourne and Brisbane that will each cover the same content. A recording of the information session will also be made available on the...

USA -
FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia

The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These patients have few treatments available...

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