Topic: regulatory affairs
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.
Next year will be a busy time for the European Medicines Agency as it looks to complete its move to Amsterdam.
EMA sounded the alarm after a staff survey found as few as 6% of its staff would move to some of the 19 cities vying to host it when it leaves London.
James Mullen has teamed up with colleagues from Biogen to help U.S. biotechs bring drugs to market in Europe.
Senior politicians in the British government have called for the country to work closely with the EMA after Brexit.