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
|