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.
Regulatory approval
Approval is a judgement that a product's benefits outweigh its risks for a defined use, made by a regulator on the evidence submitted to it. It is not a statement that a medicine is safe in the abstract, and it is not permanent.
This topic covers what regulators ask for, how their decisions differ between regions, and what an approval does and does not tell a reader.
Drug Approvals
How Are New Drugs Developed? Discovery to Approval
How new drugs are developed: target discovery, preclinical testing, clinical trials, regulatory review by FDA and EMA, manufacturing, and post-approval monitoring.
Drug Approvals
The Drug Development Process Explained
The drug development process from laboratory research to patients: translational research, decision gates, who does what, and how a medicine reaches clinical use.
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.
Biotechnology
Biotechnology in Healthcare: How Biotech Works
How biotechnology companies develop new treatments: biologics, monoclonal antibodies, mRNA, cell and gene therapy, manufacturing, funding, and regulation.
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.