C70887Level 3

Regulatory Assessment

**Semantic type:** Activity

**Definition:** A regulatory action or inaction undertaken by the regulatory authority as a result of a submission analysis and evaluation.

**Synonyms:** - RegulatoryAssessment - RegulatoryAssessment

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C128495Designate a Healthcare Setting Representative

C128496Be Able To Perform a Clinical Activity

C128497Have Necessary Healthcare Personnel or Equipment

C128500Complete Healthcare Knowledge Assessment

C128507Assess Patient Condition, Health Status, or Adverse Event

C128508Complete Patient Form

C128519Maintain Healthcare Records

C128525Complete Patient Questionnaire

C82452Both Safety and Lack of Expected Effectiveness

C82453Clinical Study Lack of Effectiveness

C82454Clinical Study Safety Issue

C82455Clinical Study Safety Issue and Lack of Effectiveness

C82456Lack of Expected Effectiveness

C82457Manufacturing Product Defect Manufacturing Defect Both Safety And LOEE

C82458Manufacturing Product Defect Manufacturing Defect LOEE

C82459Manufacturing Product Defect Manufacturing Defect Safety

C82460Manufacturing Product Defect Manufacturing Defect With No Adverse Events

C82461Safety Issue

C82477No Assessment

C82478No Attending Veterinarian

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