FDA Drug Approval Modernization Act of 1992

GPTKB entity

Statements (80)
Predicate Object
gptkbp:instance_of gptkb:legislation
gptkbp:addresses drug pricing issues
drug safety and efficacy
drug shortages
gptkbp:aims_to streamline drug approval process
gptkbp:amends gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:effective_date 1992-11-28
gptkbp:enacted_by gptkb:United_States_Congress
gptkbp:encourages development of new therapies
development of combination therapies
development of personalized medicine
development of generic drugs
patient involvement in drug development
use of biomarkers in drug development
collaboration between FDA and industry
development of digital health technologies
development of innovative drug formulations
gptkbp:enhances FDA's regulatory authority
FDA's scientific expertise
gptkbp:establishes user fees for drug applications
gptkbp:facilitates patient access to new therapies
access to clinical trial information
access to drug information for patients
access to investigational drugs
access to real-world evidence for drug approval.
communication between FDA and drug sponsors
expedited review for breakthrough therapies
international collaboration on drug regulation
https://www.w3.org/2000/01/rdf-schema#label FDA Drug Approval Modernization Act of 1992
gptkbp:impact gptkb:pharmaceuticals
gptkbp:improves patient safety measures
FDA's communication strategies
FDA's risk assessment processes
FDA's crisis management capabilities
FDA's data collection methods
FDA's public engagement efforts
FDA's risk communication strategies
gptkbp:includes provisions for pediatric drug studies
gptkbp:increased transparency in drug approval process
FDA's accountability
FDA's budget for drug review
FDA's engagement with patient advocacy groups
FDA's outreach to stakeholders
FDA's workforce capacity
gptkbp:influences subsequent drug legislation
global drug approval standards
gptkbp:introduced_in gptkb:House_of_Representatives
gptkbp:mandates post-marketing surveillance
transparency in clinical trial results
risk evaluation and mitigation strategies
evaluation of drug benefits and risks
evaluation of drug affordability
evaluation of long-term drug effects
safety monitoring for new drugs
gptkbp:promotes public health initiatives
healthcare provider education
collaboration with academic institutions
patient access to experimental drugs
innovation in drug manufacturing
advancements in clinical research methodologies
health equity in drug access
gptkbp:provides guidelines for clinical trials
gptkbp:requires safety labeling changes
annual reports on drug approvals
faster review times for new drugs
labeling changes for drugs
gptkbp:signed_by gptkb:President_George_H._W._Bush
gptkbp:supports research on rare diseases
advancements in biotechnology
research on drug interactions
research on drug efficacy
education on drug safety
clinical trial diversity
research on drug delivery systems
accelerated approval for serious conditions
orphan drug development
research on drug interactions with other therapies
research on drug metabolism
gptkbp:bfsParent gptkb:Food_and_Drug_Administration_Modernization_Act_of_1997
gptkbp:bfsLayer 6