EMA Tackles Tricky Business Of Defining Therapeutic Indications
Inconsistent Wording Makes Things Challenging For HTA Bodies And Payers
The European Medicines Agency has identified key elements that regulatory reviewers should consider when evaluating the therapeutic indications proposed by companies.
You may also be interested in...
Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.
New medicines under evaluation at the European Medicines Agency.
The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.