www.fdanews.com/articles/123299-cystic-fibrosis-drug-development-is-subject-of-emea-guideline
Cystic Fibrosis Drug Development Is Subject of EMEA Guideline
January 1, 2010
The first European Medicines Agency (EMEA)
guideline on developing products to treat cystic fibrosis advises drugmakers to use forced expiratory volume (FEV) as the primary lung-function endpoint
when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drugmakers, as should the frequency
of FEV measurements, according to the final guideline posted on the EMEA’s website last month.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor