Manipulation 4: Diabetes - Terminology (All Conditions)

M4_DSC Diabetes_Terminology_All conditions_final.docx

Data to Support Drug Product Communications as Used by the FDA

Manipulation 4: Diabetes - Terminology (All Conditions)

OMB: 0910-0695

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  1. Cautioning, Warning, Alerting


The U.S. Food and Drug Administration (FDA) is cautioning that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.


The U.S. Food and Drug Administration (FDA) is warning that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.


The U.S. Food and Drug Administration (FDA) is alerting that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.









  1. Recommending, Advising, Suggesting


The U.S. Food and Drug Administration (FDA) is recommending periodic heart rate monitoring during use of DRUG C, used to treat diabetes, because this drug may pose heart risks to patients


The U.S. Food and Drug Administration (FDA) is advising periodic heart rate monitoring during use of DRUG C, used to treat diabetes, because this drug may pose heart risks to patients


The U.S. Food and Drug Administration (FDA) is suggesting periodic heart rate monitoring during use of DRUG C, used to treat diabetes, because this drug may pose heart risks to patients




  1. Alerting, Notifying, Informing


The U.S. Food and Drug Administration (FDA) is alerting that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.


The U.S. Food and Drug Administration (FDA) is notifying that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.


The U.S. Food and Drug Administration (FDA) is informing that DRUG C, used to treat diabetes, is associated with a rare but serious skin reaction that can progress to affect other parts of the body.



  1. Evaluating, Conducting a Review of, Investigating



The U.S. Food and Drug Administration (FDA) is evaluating the risk of stroke, heart attack, and death associated with continual use of DRUG C, used to treat diabetes.


The U.S. Food and Drug Administration (FDA) is conducting a review of the risk of stroke, heart attack, and death associated with continual use of DRUG C, used to treat diabetes.


The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death associated with continual use of DRUG C, used to treat diabetes.



  1. Concluded, Determined, Found


The U.S. Food and Drug Administration (FDA) has concluded that DRUG C, used to treat diabetes, carries an increased risk of heart attack and death and is requiring updates to the drug labels to warn about this risk.


The U.S. Food and Drug Administration (FDA) has determined that DRUG C, used to treat diabetes, carries an increased risk of heart attack and death and is requiring updates to the drug labels to warn about this risk.


The U.S. Food and Drug Administration (FDA) has found that DRUG C, used to treat diabetes, carries an increased risk of heart attack and death and is requiring updates to the drug labels to warn about this risk.


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorWinthrop, Sally
File Modified0000-00-00
File Created2021-01-21

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