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June 22, 2016
The two agencies have set up a working group on involving patients in drug development.
June 10, 2016
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
June 09, 2016
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
June 01, 2016
Pharma has voiced strong opposition against Britain’s departure from the EU.
May 31, 2016
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
May 25, 2016
May 12, 2016
The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.
May 11, 2016
Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.
May 02, 2016
In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.