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In answering the following questions, please keep in mind that the FDA does not

In answering the following questions, please keep in mind that the FDA does not regulate the practice of medicine, but is responsible for providing information on the safety and efficacy of the products it regulates. As a reminder, the FDA issued a Public Health

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In answering the following questions, please keep in mind that the FDA does not

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  1. In answering the following questions, please keep in mind that the FDA does not regulate the practice of medicine, but is responsible for providing information on the safety and efficacy of the products it regulates.

  2. As a reminder, the FDA issued a Public Health Advisory on October 27, 2003 which stated: • “FDA emphasizes that these drugs must be used with caution. Prescribers are reminded of the following statement present in all antidepressant labeling:

  3. Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose”

  4. QUESTION 1 A public meeting is planned in late summer to discuss the results of further analyses of the controlled trials. Until that time, should the FDA provide additional advice to practicing physicians regarding the use of these drugs? If your answer is yes, please provide specific information on what that advice should be.

  5. QUESTION 2 Should FDA involve other professional organizations in the community? If so, how should FDA involve these organizations? What messages should these organizations provide?

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