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.
FDA
The Food and Drug Administration regulates medicines, biologics, medical devices, most food, cosmetics, tobacco and radiation-emitting products in the United States. For medicines its statutory standard is that a product be shown safe and effective for its intended use; unusually among major regulators, the agency both conducts the scientific review and takes the decision itself.
We report the FDA as an institution rather than a verdict. Its clearance and approval routes mean different things, its user-fee funding and its device pathway are the subject of long-running argument, and its decisions bind only the United States.
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.
Medical Devices
What Are Medical Devices? Types, Classes, Regulation
Medical devices explained: what counts as a device, risk classes, how FDA and EU MDR regulation works, software as a medical device, and post-market surveillance.
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
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.