Food and Drug Administration Modernization Act of 1997
GPTKB entity
Statements (61)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
legislation
|
| gptkbp:addresses |
biologics regulation
|
| gptkbp:aimsTo |
streamline drug approval process
|
| gptkbp:amends |
gptkb:Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:effectiveDate |
November 21, 1997
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:encourages |
innovation in drug manufacturing
public_participation_in_FDA_processes |
| gptkbp:enhances |
patient access to experimental drugs
|
| gptkbp:established |
clinical trial registry
|
| gptkbp:facilitates |
drug development process
|
| https://www.w3.org/2000/01/rdf-schema#label |
Food and Drug Administration Modernization Act of 1997
|
| gptkbp:impact |
healthcare_policy
|
| gptkbp:improves |
communication_between_FDA_and_industry
|
| gptkbp:influences |
FDA_policies
|
| gptkbp:introduced |
fast track approval for certain drugs
|
| gptkbp:isPartOf |
healthcare_reform
|
| gptkbp:isRelatedTo |
gptkb:FDA_advisory_committees
drug efficacy public health biotechnology consumer protection medical devices medical research patient rights healthcare regulations clinical research pharmaceutical industry adverse drug reactions pharmaceutical research drug approval process drug safety drug pricing drug recalls drug safety monitoring drug approval timelines drug innovation drug research funding drug labeling drug marketing clinical trial ethics drug approval standards drug development costs healthcare_access healthcare_costs FDA_regulations healthcare_outcomes FDA_guidelines FDA_mission FDA_inspections FDA_oversight FDA_public_health_initiatives FDA_reform |
| gptkbp:mandates |
user fees for drug applications
|
| gptkbp:promotes |
use of electronic submissions
|
| gptkbp:provides |
guidelines for dietary supplements
|
| gptkbp:reduces |
regulatory burdens on manufacturers
|
| gptkbp:requires |
labeling for off-label uses
|
| gptkbp:signature |
gptkb:Bill_Clinton
|
| gptkbp:supports |
pediatric_drug_research
|
| gptkbp:updates |
transparency_in_FDA_processes
|