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.
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 NERFINISHED ⓘ |
| 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 of America
ⓘ
surface form:
United States
|
| enactedBy | United States Congress ⓘ |
| fullName | Food and Drug Administration Modernization Act of 1997 NERFINISHED ⓘ |
| hasAbbreviation | FDAMA NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| relatedTo |
21st Century Cures Act
NERFINISHED
ⓘ
Food and Drug Administration Safety and Innovation Act NERFINISHED ⓘ Prescription Drug User Fee Act NERFINISHED ⓘ |
| sector |
biotechnology industry
ⓘ
healthcare ⓘ medical device industry ⓘ pharmaceutical industry ⓘ |
| shortName | FDA Modernization Act NERFINISHED ⓘ |
| signedBy | Bill Clinton ⓘ |
| topic |
FDA reform
ⓘ
biologics regulation ⓘ drug regulation ⓘ medical device regulation ⓘ |
| yearEnacted | 1997 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.