Data issue put Leo Pharma in the Danish Medicines Agency's crosshairs in 2021
During a good clinical practice inspection at Leo Pharma last year, the Danish Medicines Agency struggled to gain access to data related to two clinical eczema studies. The next step would have been ”regulatory action.”
by christian bundgaard, translated by daniel pedersen
Leo Pharma didn’t exactly welcome a good clinical practice (GCP) inspection by the Danish Medicines Agency with open arms last year and would have faced ”regulatory action” if it failed to hand over documents pertaining to clinical studies of eczema treatments tralokinumab and delgocitinib, industry media Dagens Pharma reports.
Already a subscriber?Log in here
Read the whole article
Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.
With your free trial you get:
- Access all locked articles
- Receive our daily newsletters
- Access our app
Get full access for you and your coworkers
Start a free company trial todayRelated articles:
Leo Pharma looking for pediatric patients for eczema trial
For subscribers
CHMP to remove 100 generic medicines from market
For subscribers
.jpg&w=384&q=75)
