Orphan drug designation criteria, benefits and the EMA new drug approval process
Treatments intended for rare diseases may not be profitable [...]
Understanding the role of a marketing authorisation holder in the regulatory submission process
In clinical research and drug development, regulatory submissions are [...]
TMC appointed UK marketing authorisation holder to drive rapid commercialisation of rare disease drug
TMC, a global clinical research organisation (CRO) dedicated to [...]
CDER establishes new ‘Center for real-World Evidence Innovation’
The FDA’s Center for Drug Evaluation and Research (CDER) [...]
The future of the rare disease landscape and the value of CRO support in this specialist area
The World Health Organization (WHO) defines a rare disease [...]