UK Clinical Trial Regulation: a practical look at the 2026 reforms
On 28 April 2026, the Medicines for Human Use [...]
FDA reinforces the single pivotal trial pathway for new drug approvals: what does this mean for your drug development?
The US Food and Drug Administration (FDA) recently reaffirmed [...]
TMC expands regulatory, medical and scientific expertise with acquisition of tranScrip
TMC is pleased to announce that tranScrip, a specialist [...]
The diagnostic odyssey: how misdiagnosis and indication broadening can undermine rare disease clinical trials
Written by Dr Victoria Datsenko, Vice President of Clinical [...]
Post-approval risk management plan updates: what changes, who owns it, and how to avoid compliance issues
In the EU and UK, a risk management plan [...]
Development safety update report writing mistakes that trigger regulator questions (and how to prevent them)
The development safety update report (DSUR) is often the [...]
Orphan Therapeutics Accelerator Expands its Network to Extend Development and Access Pathways for Ultra-Rare Disease Therapies
CAMBRIDGE, Mass., June 23, 2026 New collaborations add coordinated [...]
Drug commercialization: how to build a lean EU and UK launch model without losing control
European marketing authorization can feel like the summit. Years [...]