FDAMA
E642125
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| FDAMA canonical | 2 |
How this entity was disambiguated
This entity first appeared as the object of triple T7110978 — 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: FDAMA Context triple: [Food and Drug Administration Modernization Act of 1997, shortName, FDAMA]
-
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.
FCMA
FCMA is the commonly used abbreviation for the Fishery Conservation and Management Act, a U.S. federal law that established a comprehensive framework for managing and conserving the nation’s marine fisheries.
-
C.
FAMa
FAMa is the national military force of Mali responsible for the country’s defense and security operations.
-
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.
FDFA
FDFA is the Swiss government ministry responsible for the country’s foreign policy, diplomatic relations, and international cooperation.
- 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: FDAMA Target entity description: 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.
-
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.
FCMA
FCMA is the commonly used abbreviation for the Fishery Conservation and Management Act, a U.S. federal law that established a comprehensive framework for managing and conserving the nation’s marine fisheries.
-
C.
FAMa
FAMa is the national military force of Mali responsible for the country’s defense and security operations.
-
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.
FDFA
FDFA is the Swiss government ministry responsible for the country’s foreign policy, diplomatic relations, and international cooperation.
- F. None of above. chosen
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
health law ⓘ medical device law ⓘ pharmaceutical law ⓘ |
| affects |
biologic product approval process
ⓘ
clinical trial requirements ⓘ drug approval process ⓘ medical device premarket review ⓘ postmarketing surveillance requirements ⓘ user fee programs ⓘ |
| amends | Federal Food, Drug, and Cosmetic Act ⓘ |
| containsProvision |
expanded access to investigational drugs
ⓘ
fast track designation for serious or life-threatening conditions ⓘ modernization of food safety and labeling provisions ⓘ recognition of national uniformity for nonprescription drugs ⓘ reforms to device premarket notification (510(k)) process ⓘ regulation of pharmacy compounding ⓘ renewal and expansion of prescription drug user fees ⓘ standards for dissemination of information on off-label uses ⓘ |
| country |
United States
ⓘ
linked to:
United States of America
|
| enactedBy | United States Congress ⓘ |
| fullName | Food and Drug Administration Modernization Act of 1997 ⓘ |
| hasAbbreviation | FDAMA ⓘ |
| jurisdiction | federal ⓘ |
| legalStatus | in force ⓘ |
| purpose |
to accelerate approval of new drugs and biologics
ⓘ
to clarify FDA authority over advertising and promotion ⓘ to improve patient access to experimental therapies ⓘ to modernize and streamline FDA regulatory processes ⓘ to reform medical device regulation ⓘ |
| regulates |
biologics
ⓘ
cosmetics ⓘ drugs ⓘ food ⓘ medical devices ⓘ |
| regulatoryBody |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| relatedTo |
21st Century Cures Act
ⓘ
Food and Drug Administration Safety and Innovation Act ⓘ Prescription Drug User Fee Act ⓘ
linked to:
Prescription Drug User Fee Act of 1992
|
| sector |
biotechnology industry
ⓘ
healthcare ⓘ medical device industry ⓘ pharmaceutical industry ⓘ |
| shortName | FDA Modernization Act ⓘ |
| signedBy | Bill Clinton ⓘ |
| topic |
FDA reform
ⓘ
biologics regulation ⓘ drug regulation ⓘ medical device regulation ⓘ |
| yearEnacted | 1997 ⓘ |
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: FDAMA Description of subject: 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.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.