Brexit Talks Must Prioritize Patient Access, Avoid Regulatory Divergence – EFPIA
Executive Summary
European industry federation says patient access to new drugs must be a priority in the negotiations over the UK's exit from the EU, as must the need to ensure that the UK and EU drug regulatory systems don't diverge.
You may also be interested in...
Brain Drain And Recruitment Risks for EMA post UK Brexit Vote
Retaining existing and recruiting new staff could be a challenge for the London-based European Medicines Agency as a result of the uncertainty over the future location of the agency following the decision by the UK to leave the EU.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.