: Public Class
DEFINITION:<br /></p><p>An evaluation of a submission by a regulatory body. <br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>The FDA evaluates a submission for a new drug or device. <br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
- Attributes
- Associations To
- Associations From
- Tagged Values
- Constraints
| Attribute |
Public DSET<II>
identifier
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 Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to * |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:AE=Authorization.approvalId
Map:CTR&Rr2=MA number
Map:CTR&Rr2=Orphan drug number
Map:CTR&Rr2=Manufacturer authorisation number
Map:CTRPv1.0=TherapeuticProduct.identifier
Map:CTRRr3=RegulatoryAssessment.identifier
Map:CTRv1.0=RegulatoryAssessment.identifier
Map:ICSRr2=Approval.id (in R_Product)
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes identity of the regulatory assessment.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;New Drug Application (NDA) number, Investigational New Drug (IND) number, Biologic License Application (BLA), Premarket Approval (PMA), 510K#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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Public CD
typeCode
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTRv1.0=RegulatoryAssessment.typeCode
Map:HSDBv1.0=[IND/IDE] .Grantor
Map:ICSRr2=Approval.code (in R_Product)
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the approval process used by the regulatory authority.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;FDA's Center for Devices and Radiological Health (CDRH) Process, FDA's Center for Drug Evaluation and Research (CDER) Process#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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Public CD
resultCode
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:1. to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTGOV=Expanded Access Status
Map:CTR&Rr2=IEC Opinion Given
Map:CTR&Rr2=GMP MP Auth granted
Map:CTRPv3.8=StudyIndIde.expandedAccessStatusCode
Map:CTRR=Expanded access indicator
Map:CTRRr3=RegulatoryAssessment.assessmentCode
Map:CTRRr3=StudyAgent.expandedAccessStatusCode
Map:CTRv1.0=RegulatoryAssessment.resultCode
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the regulatory designation made by the regulatory authority.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For regular submissions the code can be: approved, not approvable, approvable, complete response or cleared.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For expanded access submissions the code can be: Available, No longer available, Temporarily not available, or Approved for marketing.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For some submissions, there are business processes that will make "default" action based on timelines --i.e., if no action is taken, then the submission is "approved". #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For a submission, there may be multiple regulatory assessments that correspond to the state transitions for a submission, but only one regulatory assessment is true at a given time. A submission can first be "approvable" and then when the data is complete, a new regulatory assessment can be made that is "approved". #lt;br /#gt;#lt;/p#gt;
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Public CD
reasonCode
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTR&Rr2=Reason for no authorisation
Map:CTR&Rr2=IEC Opinion not favourable reasons
Map:CTRRr3=RegulatoryAssessment.assessmentReasonCode
Map:CTRv1.0=RegulatoryAssessment.reasonCode
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the rationale for a regulatory designation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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Public CD
statusCode
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTRRr3=RegulatoryAssessment.statusCode
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the phase in the lifecycle of the assessment.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;pending, complete#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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Public TS.DATETIME
completionDate
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTGOV=Expanded Access Status
Map:CTR&Rr2=IEC Opinion date
Map:CTRR=Expanded access indicator
Map:CTRRr3=RegulatoryAssessment.assessmentDate
Map:CTRv1.0=RegulatoryAssessment.completionDate
Map:ICSRr2=Author2.time (in R_Product)
Map:ICSRr2=Approval.effectiveTime (in R_Product)
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which this particular assessment is completed.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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Public TS.DATETIME
expectedResubmissionDate
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Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:CTRRr3=RegulatoryAssessment.expectedResubmissionDate
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date on which the resubmission of the regulatory application is expected.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S): #lt;br /#gt;#lt;/p#gt;#lt;p#gt;Used only when RegulatoryAssessment.statusCode is not complete.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Regulatory authorities typically assign a resubmission deadline such as 30 days.#lt;br /#gt;#lt;/p#gt;
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| Element |
Source Role |
Target Role |
RegulatoryAuthority
Class
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Name: performedRegulatoryAssessment
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Name: performingRegulatoryAuthority
|
 Details:
DESCRIPTION:<br /></p><p>Each RegulatoryAssessment always is performed by one RegulatoryAuthority. Each RegulatoryAuthority might perform one or more RegulatoryAssessment.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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| Element |
Source Role |
Target Role |
Submission
Class
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Name: evaluatedSubmission
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Name: evaluatingRegulatoryAssessment
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Details:
DESCRIPTION:<br /></p><p>Each Submission might be evaluated in one RegulatoryAssessment. Each RegulatoryAssessment always evaluates one or more Submission. <br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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| Tag |
Value |
| Map:AE |
Authorization |
Details:
|
| Map:CTRRr3 |
RegulatoryAssessment |
Details:
|
| Map:CTRv1.0 |
RegulatoryAssessment |
Details:
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| Map:ICSRr2 |
Approval (in R_Product) |
Details:
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| Constraint |
Type |
Status |
| is a function performed by actualIndicator Qualifier |
Invariant |
Approved |
Details:
Only Organization (via OversightAuthority) with actualIndicator = "true" is valid.
|