Adaptive licensing: Is the EMA's Rasi heading for a fight with the commission and others in EU?
This article was originally published in SRA
The European Commission and German health technology assessors have poured cold water on aspirations by European Medicines Agency head Guido Rasi to introduce an adaptive licensing approach for evaluating and approving medicines.
You may also be interested in...
The European Medicines Agency has dismissed a call to stop accepting applications for its adaptive pathways program until it has better evidence on how to use real-world data.
The European Medicines Agency has released its keenly awaited final report on it adaptive pathways pilot and says it will continue to accept applications for the new drug development concept. Meanwhile, law firm Bristows highlights the hurdles ahead for applicants.
The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.