Kefauver–Harris Drug Amendments of 1962
E165701
The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
All labels observed (5)
| Label | Occurrences |
|---|---|
| Drug Efficacy Amendments of 1962 | 1 |
| Kefauver–Harris Amendments | 1 |
| Kefauver–Harris Amendments of 1962 | 1 |
| Kefauver–Harris Drug Amendments | 1 |
| Kefauver–Harris Drug Amendments of 1962 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1445195 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Kefauver–Harris Drug Amendments of 1962 Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Kefauver–Harris Drug Amendments of 1962]
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A.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
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B.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
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C.
Pure Food and Drug Act of 1906
The Pure Food and Drug Act of 1906 was a landmark U.S. federal law that laid the foundation for modern consumer protection by prohibiting the manufacture and sale of adulterated or misbranded foods and drugs and leading to the creation of federal regulatory oversight.
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D.
1969 Public Health Cigarette Smoking Act
The 1969 Public Health Cigarette Smoking Act was a U.S. federal law that significantly strengthened cigarette labeling requirements and banned cigarette advertising on television and radio to reduce smoking-related health risks.
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E.
Aldrich–Vreeland Act
The Aldrich–Vreeland Act was a 1908 U.S. law that created emergency currency provisions and laid groundwork for banking reform in response to the Panic of 1907.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Kefauver–Harris Drug Amendments of 1962 Target entity description: The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
-
A.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
-
B.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
-
C.
Pure Food and Drug Act of 1906
The Pure Food and Drug Act of 1906 was a landmark U.S. federal law that laid the foundation for modern consumer protection by prohibiting the manufacture and sale of adulterated or misbranded foods and drugs and leading to the creation of federal regulatory oversight.
-
D.
1969 Public Health Cigarette Smoking Act
The 1969 Public Health Cigarette Smoking Act was a U.S. federal law that significantly strengthened cigarette labeling requirements and banned cigarette advertising on television and radio to reduce smoking-related health risks.
-
E.
Aldrich–Vreeland Act
The Aldrich–Vreeland Act was a 1908 U.S. law that created emergency currency provisions and laid groundwork for banking reform in response to the Panic of 1907.
- F. None of above. chosen
Statements (45)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
drug regulation ⓘ |
| administeredBy |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| alsoKnownAs |
Drug Efficacy Amendments of 1962
ⓘ
linked to:
Kefauver–Harris Drug Amendments of 1962
|
| amends | Federal Food, Drug, and Cosmetic Act ⓘ |
| appliesTo |
drugs approved between 1938 and 1962 for efficacy review
ⓘ
new drug applications ⓘ pharmaceutical drugs ⓘ |
| country |
United States
ⓘ
linked to:
United States of America
|
| enactedBy | United States Congress ⓘ |
| establishes | efficacy requirement for drug approval ⓘ |
| focusesOn |
drug efficacy
ⓘ
drug manufacturing quality ⓘ drug safety ⓘ pharmaceutical marketing practices ⓘ |
| goal |
to protect the public from ineffective drugs
ⓘ
to protect the public from unsafe drugs ⓘ |
| historicalContext | enacted in response to the thalidomide tragedy ⓘ |
| impact |
established modern standards for clinical trials in the U.S.
ⓘ
significantly lengthened the drug approval process ⓘ |
| introduced |
FDA oversight of clinical investigations
ⓘ
good manufacturing practice standards for drugs ⓘ requirement for informed consent of clinical trial subjects ⓘ requirements for reporting adverse drug reactions ⓘ |
| legalEffect |
expanded FDA control over prescription drug advertising
ⓘ
increased premarket testing requirements for drugs ⓘ made proof of efficacy a prerequisite for FDA approval ⓘ required periodic reporting on drug safety ⓘ |
| mandates |
that drug advertising disclose accurate information about effectiveness
ⓘ
that drug advertising disclose accurate information about side effects ⓘ |
| namedAfter |
Estes Kefauver
ⓘ
Oren Harris ⓘ |
| regulates |
drug labeling claims
ⓘ
prescription drug advertising to physicians ⓘ |
| requires |
adequate and well-controlled clinical investigations
ⓘ
proof of safety for new drugs ⓘ substantial evidence of effectiveness before marketing ⓘ |
| shortName |
Kefauver–Harris Amendments
ⓘ
linked to:
Kefauver–Harris Drug Amendments of 1962
|
| signedBy | John F. Kennedy ⓘ |
| signingDate | 1962-10-10 ⓘ |
| strengthens |
FDA authority over drug advertising
ⓘ
FDA authority over drug approval ⓘ FDA authority over drug labeling ⓘ FDA authority over drug manufacturing ⓘ |
| yearEnacted | 1962 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Kefauver–Harris Drug Amendments of 1962 Description of subject: The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
Referenced by (5)
Full triples — surface form annotated when it differs from this entity's canonical label.
linked to: Kefauver–Harris Drug Amendments of 1962
linked to: Kefauver–Harris Drug Amendments of 1962
linked to: Kefauver–Harris Drug Amendments of 1962
linked to: Kefauver–Harris Drug Amendments of 1962