Topic: regulatory affairs
LabCorp acquired postmarket services provider Sciformix and plans to integrate it with Covance. The terms of the deal were not disclosed.
Oncologie launched operations in Boston and Shanghai with a $16.5 million seed round, aiming to deliver drugs to China and the U.S. simultaneously.
New Chinese data management and transfer rules passed this year could be tripping up global pharma collaborations and research.
The European Medicines Agency has begun laying the foundation for its new Amsterdam headquarters, aiming to finish construction by November 2019.
Regulatory officials view the online vision test app as a device and as such want Opternative to file for premarket approval.
Republicans plan to return to the topic and could push legislation through under rules that would only require them to get a majority.
The proposal jibes with the wishes of the biopharma industry, but it remains to be seen whether the European Union is receptive to the idea.
The precipitous drop in the amount of space available to the EMA will force the agency to hold meetings off-site.
Implementations of the Cures Act in the U.S. and the upcoming General Data Protection Regulation in the EU are ACRO's top priorities in 2018.
Gottlieb talked up the prospect of releasing redacted CRLs in his confirmation hearings but has now watered down his interest in the idea.