Clinical Trials
Clinical Trial Phases Explained: Phase 1 to Approval
Clinical trial phases explained: what happens in Phase 1, 2, 3 and 4, how each stage is designed, and how trial evidence supports FDA and EMA approval.
Expedited approval pathways
Every major regulator operates routes that reach a decision sooner for serious conditions with unmet need: accelerated approval, priority review and breakthrough designation in the United States; conditional marketing authorisation, accelerated assessment and PRIME in the European Union. They change the timing and sequence of evidence, and often permit a surrogate endpoint, but not the requirement for a favourable benefit-risk balance.
These pathways are where the trade-off between speed and certainty is made explicit, and where confirmatory evidence is promised and sometimes not delivered. We report both halves.
Drug Approvals
What Is Drug Approval? How FDA and EMA Decide
How drug approval works: what regulators assess, how FDA and EMA review differ, expedited pathways, conditional approvals, and what happens after authorisation.
Drug Regulation
FDA Explained: What the U.S. FDA Does
What the FDA does: regulating medicines, biologics, medical devices, food and tobacco, how review and inspection work, its centres, powers and known criticisms.
Drug Regulation
EMA Explained: How Europe Regulates Medicines
What the European Medicines Agency does: the centralised procedure, CHMP and PRAC, marketing authorisation, pharmacovigilance, and how EMA differs from the FDA.
Drug Regulation
How New Medicines Are Approved: FDA and EMA Paths
FDA and EMA regulatory pathways compared: standard and expedited routes, evidence requirements, decision structures, and why approvals differ between regions.