Food and Drug Administration Modernization Act
GPTKB entity
Statements (62)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legislation
|
| gptkbp:addresses |
counterfeit drugs
healthcare disparities drug shortages |
| gptkbp:affects |
medical device regulation
|
| gptkbp:amended_by |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:effective_date |
gptkb:1997
|
| gptkbp:enacted_by |
gptkb:legislation
|
| gptkbp:encourages |
collaboration with industry
development of combination therapies development of new antibiotics use of electronic submissions development of digital therapeutics patient involvement in drug development |
| gptkbp:enhances |
FDA's authority
FDA's communication with stakeholders |
| gptkbp:established |
user fees for drug applications
|
| gptkbp:facilitates |
generic drug approval
international drug approval processes access to biosimilars access to clinical trial data |
| https://www.w3.org/2000/01/rdf-schema#label |
Food and Drug Administration Modernization Act
|
| gptkbp:impact |
clinical trials
|
| gptkbp:improves |
FDA's efficiency
|
| gptkbp:includes_provisions_for |
pediatric drug testing
|
| gptkbp:increased |
transparency in drug approval process
FDA's budget |
| gptkbp:influences |
gptkb:healthcare_organization
biotechnology regulations drug pricing policies pharmaceutical marketing practices healthcare technology assessment. |
| gptkbp:introduced |
gptkb:legislation
|
| gptkbp:mandates |
adverse event reporting
safety labeling changes risk evaluation and mitigation strategies |
| gptkbp:promotes |
public health
supply chain security research on rare diseases safety and efficacy of drugs fast track approval use of biomarkers in drug development |
| gptkbp:provides |
incentives for orphan drugs
|
| gptkbp:purpose |
streamline drug approval process
|
| gptkbp:repealed_by |
FDA's drug approval process
|
| gptkbp:requires |
clinical trial registration
post-market surveillance annual reports on drug safety FDA to report on drug shortages labeling of off-label uses |
| gptkbp:signed_by |
gptkb:Bill_Clinton
|
| gptkbp:supports |
innovation in drug development
advancements in personalized medicine advancements in telemedicine advancements in vaccine development research on drug interactions research on drug safety patient access to experimental drugs development of regenerative medicine education on drug risks |
| gptkbp:bfsParent |
gptkb:Animal_Drug_User_Fee_Act
|
| gptkbp:bfsLayer |
5
|