Food and Drug Administration
Medicine approval agency
The Food and Drug Administration is the U.S. federal agency responsible for regulating food safety, pharmaceuticals, medical devices, cosmetics, and tobacco products.
Usually called the FDA: The FDA approved the new vaccine.
The agency reviews drugs before they can be sold and can recall unsafe products from the market.
Memory retrieval act
- toxicologyScience of poisons
- risk assessmentEvaluating likelihood of harm
- hazardSource of potential harm
- warningAlert about danger
protection · prevention · surveillance · biosecurity · black box warning · side effects · drug interactions · contamination
Controlled health research experiments
- pharmaceuticalsManufactured therapeutic substances
- biologicsDrugs derived from organisms
- medical devicesTools for patient care
- therapeuticsStudy of healing interventions
vaccines · prescription · over-the-counter · efficacy · NDA · fast track · orphan drug · generic drugs
Standard or attribute
- purityUncontaminated quality
- potencyDegree of strength
- labelingAssigning identifying markers
- specificationsStated requirements and parameters
GMP · USP · monograph · criteria · formulation · stability · identity · strength
Formal accounts examination
- site visitIn-person location inspection
- quality controlMaintaining production standards
- evaluationDetermining worth or quality
- verificationProving something accurate
examination · investigation · enforcement · sampling · laboratory testing · field office · consent decree · injunction
Adopted principle of action
- enforcementCompelling compliance with rules
- legislationOfficial enactment of statutes
- oversightSupervision or inadvertent omission
- authorityPower to enforce obedience
governance · jurisdiction · rules · law · monitoring · control · supervision · directive
recall
Memory retrieval act
- toxicologyScience of poisons
- risk assessmentEvaluating likelihood of harm
- hazardSource of potential harm
warning · protection · prevention · surveillance · biosecurity · black box warning · side effects · drug interactions · contamination · outbreak
clinical trials
Controlled health research experiments
- pharmaceuticalsManufactured therapeutic substances
- biologicsDrugs derived from organisms
- medical devicesTools for patient care
therapeutics · vaccines · prescription · over-the-counter · efficacy · NDA · fast track · orphan drug · generic drugs · biosimilars
quality
Standard or attribute
specifications · GMP · USP · monograph · criteria · formulation · stability · identity · strength · bioavailability
audit
Formal accounts examination
- site visitIn-person location inspection
- quality controlMaintaining production standards
- evaluationDetermining worth or quality
verification · examination · investigation · enforcement · sampling · laboratory testing · field office · consent decree · injunction · seizure
policy
Adopted principle of action
- enforcementCompelling compliance with rules
- legislationOfficial enactment of statutes
- oversightSupervision or inadvertent omission
authority · governance · jurisdiction · rules · law · monitoring · control · supervision · directive · mandate
Food and Drug Administrationpharmaceutical companies
Firms producing medicinal drugs
Big Pharma · Pfizer · Johnson & Johnson · Merck · Purdue Pharma
Food and Drug Administrationfree market
Commerce without state intervention
deregulation · laissez-faire · black market · caveat emptor · gray market
Food and Drug Administrationsnake oil
Fraudulent cure-all
quackery · patent medicine · counterfeit drugs · thalidomide · The Jungle
administration, administer, administrate, administrative, administrator, administrators, administered, administering, fodder