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.
Marketing authorisation
A marketing authorisation is permission to sell a medicine for a stated use, on stated terms. It carries obligations — labelling, monitoring, sometimes further studies — and it can be varied, suspended or withdrawn.
We report on what authorisations actually permit, and on the conditional and accelerated routes that trade evidence at approval for evidence afterwards.
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.
Medical Device Regulation
Medical Device Regulation Explained: Route to Market
How medical device regulation works: risk classification, FDA pathways, EU MDR and notified bodies, clinical evidence, software rules and post-market surveillance.