Statements (45)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:European_Union_Regulation
|
| gptkbp:aimsTo |
clinical trial design
|
| gptkbp:allows |
rolling review of applications
|
| gptkbp:appliesTo |
unmet medical needs
serious conditions |
| gptkbp:associated_with |
increased_collaboration_with_FDA
|
| gptkbp:awardedBy |
criteria are no longer met
|
| gptkbp:benefits |
patients with limited treatment options
|
| gptkbp:established |
gptkb:FDA_Modernization_Act_of_1997
|
| gptkbp:has_a |
Standard_Review_process
|
| gptkbp:heldIn |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Fast Track Designation
|
| gptkbp:influenced |
scientific evidence
|
| gptkbp:involves |
early clinical data submission
|
| gptkbp:is_a |
expedited review process
|
| gptkbp:is_a_subject_of |
FDA_guidelines
|
| gptkbp:is_a_time_for |
accelerating access to important therapies
|
| gptkbp:is_a_tool_for |
accelerating drug development
|
| gptkbp:is_accessible_by |
sponsors of drug development
|
| gptkbp:is_aimed_at |
improving patient access to therapies
|
| gptkbp:is_designed_to |
reduce time to market
support innovation in drug development therapies for life-threatening diseases therapies for serious conditions |
| gptkbp:is_essential_for |
FDA's_drug_approval_process
|
| gptkbp:is_evaluated_by |
clinical need
|
| gptkbp:is_monitored_by |
FDA_review_teams
|
| gptkbp:is_part_of |
gptkb:FDA's_expedited_programs
FDA's_commitment_to_public_health FDA's_efforts_to_streamline_drug_approval FDA's_regulatory_framework |
| gptkbp:is_used_in |
pharmaceutical companies
|
| gptkbp:leads |
Accelerated Approval
Priority Review |
| gptkbp:provides |
more_frequent_communication_with_FDA
|
| gptkbp:purpose |
facilitate development of drugs
|
| gptkbp:relatedTo |
Breakthrough_Therapy_Designation
|
| gptkbp:requires |
submission of clinical data
|
| gptkbp:suitableFor |
biologics
drugs orphan drugs new molecular entities a guarantee of approval new indications for approved drugs |
| gptkbp:was_a_response_to |
public health emergencies
|