FDAAA
E647146
FDAAA is a U.S. federal law enacted in 2007 that expanded the Food and Drug Administration’s authority over drug and device safety, clinical trial registration, and post-market surveillance.
All labels observed (1)
| Label | Occurrences |
|---|---|
| FDAAA canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7168826 — 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: FDAAA Context triple: [Food and Drug Administration Amendments Act of 2007, abbreviation, FDAAA]
-
A.
FDHA
The FDHA is Switzerland’s Federal Department of Home Affairs, responsible for areas such as social insurance, public health, culture, and statistics at the national level.
-
B.
FDAMA
FDAMA is a U.S. federal law enacted in 1997 that overhauled and streamlined Food and Drug Administration regulatory processes for drugs, biologics, and medical devices.
-
C.
FAST Act
The FAST Act is a U.S. federal law that authorizes long-term funding and policy for the nation’s surface transportation infrastructure, including highways, transit, and rail.
-
D.
FDIA
FDIA is the commonly used abbreviation for the Federal Deposit Insurance Act, the U.S. law that established federal insurance for bank deposits to protect consumers and promote financial stability.
-
E.
DFFR
DFFR is the abbreviation for the Swiss Federal Department of Economic Affairs, Education and Research, a government ministry responsible for national economic policy, education, and research.
- 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: FDAAA Target entity description: FDAAA is a U.S. federal law enacted in 2007 that expanded the Food and Drug Administration’s authority over drug and device safety, clinical trial registration, and post-market surveillance.
-
A.
FDHA
The FDHA is Switzerland’s Federal Department of Home Affairs, responsible for areas such as social insurance, public health, culture, and statistics at the national level.
-
B.
FDAMA
FDAMA is a U.S. federal law enacted in 1997 that overhauled and streamlined Food and Drug Administration regulatory processes for drugs, biologics, and medical devices.
-
C.
FAST Act
The FAST Act is a U.S. federal law that authorizes long-term funding and policy for the nation’s surface transportation infrastructure, including highways, transit, and rail.
-
D.
FDIA
FDIA is the commonly used abbreviation for the Federal Deposit Insurance Act, the U.S. law that established federal insurance for bank deposits to protect consumers and promote financial stability.
-
E.
DFFR
DFFR is the abbreviation for the Swiss Federal Department of Economic Affairs, Education and Research, a government ministry responsible for national economic policy, education, and research.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
drug regulation law ⓘ health law ⓘ medical device regulation law ⓘ |
| abbreviationFor | Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ |
| affects |
clinical investigators
ⓘ
clinical trial sponsors ⓘ medical device manufacturers ⓘ pharmaceutical manufacturers ⓘ |
| aimsTo |
improve drug safety monitoring
ⓘ
increase transparency of clinical research ⓘ strengthen post-market surveillance ⓘ |
| amends | Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ |
| authorizes |
FDA to require Risk Evaluation and Mitigation Strategies
ⓘ
FDA to require post-marketing clinical trials ⓘ FDA to require post-marketing studies ⓘ |
| containsProvision |
Section 801 – Expanded Clinical Trial Registry Data Bank
NERFINISHED
ⓘ
Title VIII – Clinical Trial Databases NERFINISHED ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| creates | Risk Evaluation and Mitigation Strategies program NERFINISHED ⓘ |
| effectiveIn | United States NERFINISHED ⓘ |
| enactedBy | United States Congress ⓘ |
| establishes | expanded post-marketing safety authorities for FDA ⓘ |
| expandsAuthorityOf | U.S. Food and Drug Administration NERFINISHED ⓘ |
| fullName | Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ |
| hasKeyConcept |
Risk Evaluation and Mitigation Strategies (REMS)
NERFINISHED
ⓘ
clinical trial registry ⓘ clinical trial results database ⓘ post-market risk management ⓘ |
| jurisdiction | federal ⓘ |
| regulates |
biological products
ⓘ
clinical trial registration ⓘ clinical trial results reporting ⓘ drug safety ⓘ medical device safety ⓘ post-market device surveillance ⓘ post-market drug surveillance ⓘ |
| requires |
adverse event reporting for certain trials
ⓘ
registration of applicable clinical trials on ClinicalTrials.gov ⓘ results reporting for certain clinical trials on ClinicalTrials.gov ⓘ submission of basic summary results information ⓘ |
| signedBy | George W. Bush ⓘ |
| signingDate | 2007-09-27 ⓘ |
| subjectArea |
clinical research regulation
ⓘ
medical device regulation ⓘ pharmaceutical regulation ⓘ public health ⓘ |
| yearEnacted | 2007 ⓘ |
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: FDAAA Description of subject: FDAAA is a U.S. federal law enacted in 2007 that expanded the Food and Drug Administration’s authority over drug and device safety, clinical trial registration, and post-market surveillance.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.