Food and Drug Administration Modernization Act of 1997
GPTKB entity
Statements (57)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legislation
|
| gptkbp:addresses |
drug shortages
advertising of prescription drugs |
| gptkbp:amends |
gptkb:Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:effective_date |
November 21, 1997
|
| gptkbp:enacted_by |
gptkb:United_States_Congress
|
| gptkbp:encourages |
research on rare diseases
development of combination therapies development of personalized medicine use of electronic submissions collaboration with international regulatory agencies |
| gptkbp:enhances |
FDA's ability to respond to public health emergencies
FDA's authority over drug compounding FDA's enforcement capabilities FDA's role in food safety |
| gptkbp:establishes |
clinical trial registry
user fees for drug applications |
| gptkbp:facilitates |
access to clinical trial information
access to medical devices access to new therapies for patients. fast track designation for drugs |
| https://www.w3.org/2000/01/rdf-schema#label |
Food and Drug Administration Modernization Act of 1997
|
| gptkbp:impact |
accelerated approval of drugs
|
| gptkbp:improves |
transparency in drug approval process
FDA's communication with healthcare providers FDA's review process FDA's risk assessment processes communication between FDA and industry |
| gptkbp:includes |
provisions for dietary supplements
|
| gptkbp:increased |
FDA's budget
|
| gptkbp:influences |
biotechnology regulations
|
| gptkbp:introduced_in |
gptkb:House_of_Representatives
|
| gptkbp:mandates |
training for FDA staff
reporting of adverse drug reactions post-market surveillance of drugs patient involvement in drug development |
| gptkbp:promotes |
public health initiatives
innovation in drug development patient access to experimental drugs use of biomarkers in drug development |
| gptkbp:provides |
incentives for orphan drug development
|
| gptkbp:purpose |
streamline drug approval process
|
| gptkbp:repealed_by |
gptkb:FDA_Drug_Approval_Modernization_Act_of_1992
|
| gptkbp:requires |
labeling of food additives
risk evaluation and mitigation strategies safety reporting for drugs |
| gptkbp:signed_by |
gptkb:Bill_Clinton
|
| gptkbp:supports |
research on drug interactions
research on drug efficacy public education on drug safety generic drug competition clinical trial diversity pediatric drug research research on drug safety in special populations |
| gptkbp:bfsParent |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:Food,_Drug,_and_Cosmetic_Act |
| gptkbp:bfsLayer |
5
|