Rare Conversations podcast: TMC’s Legacy & Professional Expertise
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 [...]
FDA provides new guidance on conducting clinical trials with decentralised elements
Clinical studies have traditionally required participants to come to [...]
Rare Conversations podcast: the future of the rare disease landscape with Simon Estcourt
In this podcast, the first in our Rare Conversations [...]
How to get an EMA marketing authorisation
Obtaining marketing authorisation in Europe can be a complex [...]
Getting an EU marketing authorisation for orphan drugs
Thanks to its large population and well-established healthcare system, [...]
Revised Declaration of Helsinki adopted by the global medical community
The principles of Good Clinical Practice (GCP) are derived [...]
CDER releases annual ‘Accelerating Rare Disease Cures (ARC) Program’ report for 2024
The FDA’s Center For Drug Evaluation and Research (CDER) [...]
The role of pharmacovigilance in oncology drug trials
Some of our experts recently penned a thought-provoking article [...]