FDA orphan drug designation vs. EMA orphan drug designation
Orphan drug designation (ODD) is granted to drugs that [...]
How can marketing authorisation holders overcome these 5 post-approval regulatory challenges?
Bringing a new drug to market doesn't end with [...]
TMC Secures MHRA UK Authorisation for Rare Disease Product in the United Kingdom
TMC, a global clinical research organisation (CRO) dedicated to [...]
What you need to know about regulatory submissions for a successful CTA or MAA
Regulatory submissions are essential for obtaining the necessary approvals [...]
Gaining 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 [...]