drug approval
Pharmaceutical market clearance
Drug approval is the formal process by which a regulatory authority certifies that a medication is safe and effective for public use.
In the United States, the Food and Drug Administration grants approval after reviewing clinical trial data; other countries have equivalent agencies.
The new cancer treatment is awaiting drug approval.
A drug's approval status determines whether it can be legally prescribed or sold.
- FDAU.S. health regulator
- pharmaceutical companiesFirms producing medicinal drugs
- efficacyAbility to produce results
- NDASecrecy contract, abbreviated
- bioequivalenceEqual drug delivery profile
side effects · patient safety · IND · WHO · ethics committees · recalls · informed consent · endpoints · risk-benefit analysis · randomization · statisticians · biomarkers · legal advisors · fast track · phase three · healthcare providers · statistical significance · pharmacokinetics
- FDA regulationFDA, medical devices, food labeling, food additives, dietary supplements
- bioregulationbiosafety, bioethics, human subjects, informed consent, clinical guidelines
- drug researchclinical trials, pharmacology, pharmacokinetics, toxicology, efficacy
- Drug RegulationFDA, DEA, controlled substances, Schedule II, narcotics
- health lawhealthcare laws, health law, medical law, insurance law, vaccination mandates
- health lawshealth law, Obamacare, health standards, health regulations, healthcare mandates
drug approvaldrug recall
Removing unsafe medication from sale
delisting · license suspension · ban · phase-out · black box warning
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