FDA
Medicine approval bureau
FDA is the Food and Drug Administration, the U.S. federal agency responsible for regulating food safety, pharmaceuticals, medical devices, and cosmetics.
The FDA approves new drugs before they can be sold, inspects food processing facilities, and issues recalls for unsafe products: The FDA hasn't approved that treatment yet.
Favorable opinion given
- complianceAdhering to requirements
- guidelinesSuggested rules for behavior
- standardsAccepted levels of quality
- enforcementCompelling compliance with rules
oversight · requirements · inspection · certification · auditing · monitoring · documentation · submission
Memory retrieval act
- contaminationIntroduction of impurities
- inspectionFormal assessment of condition
- labelingAssigning identifying markers
- allergensImmune reaction triggers
additives · preservatives · nutrition facts · shelf life · pasteurization · sanitation · hygiene · pathogens
Human subject research experiment
- drug approvalRegulatory clearance for pharmaceuticals
- therapeuticsStudy of healing interventions
- biologicsDrugs derived from organisms
- genericNot brand-name
prescription · over-the-counter · efficacy · safety · dosage · side effect · black box warning · orphan drug
Tool for clinical use
- clearancePermitted passage or approval
- PMAHopeful psychological disposition
- implantDevice placed inside tissue
- diagnosticTest to identify problems
recall · biocompatibility · sterilization · software · wearable · pacemaker · insulin pump · MRI
Paper-wrapped tobacco for smoking
- e-cigarettesBattery-powered nicotine inhalers
- vapingUsing electronic cigarettes
- nicotineAddictive tobacco alkaloid
- warning labelsNotices of potential danger
approval
Favorable opinion given
- complianceAdhering to requirements
- guidelinesSuggested rules for behavior
- standardsAccepted levels of quality
enforcement · oversight · requirements · inspection · certification · auditing · monitoring · documentation · submission · protocol
recall
Memory retrieval act
- contaminationIntroduction of impurities
- inspectionFormal assessment of condition
- labelingAssigning identifying markers
allergens · additives · preservatives · nutrition facts · shelf life · pasteurization · sanitation · hygiene · pathogens · outbreak
clinical trial
Human subject research experiment
- drug approvalRegulatory clearance for pharmaceuticals
- therapeuticsStudy of healing interventions
- biologicsDrugs derived from organisms
generic · prescription · over-the-counter · efficacy · safety · dosage · side effect · black box warning · orphan drug · fast track
medical device
Tool for clinical use
- clearancePermitted passage or approval
- PMAHopeful psychological disposition
- implantDevice placed inside tissue
diagnostic · recall · biocompatibility · sterilization · software · wearable · pacemaker · insulin pump · MRI · prosthetic
cigarettes
Paper-wrapped tobacco for smoking
- e-cigarettesBattery-powered nicotine inhalers
- vapingUsing electronic cigarettes
- nicotineAddictive tobacco alkaloid
warning labels · smokeless · cigars · menthol
- Safety organizationsOSHA, Red Cross, NHTSA, CDC, WHO
- Drug RegulationDEA, controlled substances, drug scheduling, Schedule II, drug approval
- FDA regulationdrug approval, medical devices, prescription drugs, dietary supplements, recalls
- federal agenciesFBI, CIA, EPA, IRS, CDC
- food lawUSDA, labeling, nutrition facts, recall, inspection
- food policyUSDA, dietary guidelines, nutrition facts, school lunch, WIC
FDABig Pharma
Major medication corporations collectively
Pfizer · Johnson & Johnson · Merck · drug company · Monsanto
FDAderegulation
Removing governmental business restrictions
free market · laissez-faire · caveat emptor · buyer beware · black market
- FDA banAgency-imposed market removal
- FDA approvalOfficial drug safety certification
- FDA approvedCleared by regulators