Health Medical Homework Help

• Goal:
  • Students have a chance to draft a response to a FDA Warning Letter response with this assignment
  • Use the Template below to write a response to the “Warning Letter”
  • Your response is a type of persuasive document
  • Your goal is to convince the reviewers at the FDA of your ability to correct violations and your sincerity and commitment in working with the FDA through the process
  • Address (2) outlined violations in your response letter per the instructions on this page and guidance you find in resources in Learning Materials
  • Some of these resources are direct examples of what a response letter should look like:
    • see FDA Warning Letters / filter by Response Letter column for numerous examples
  • A Template will walk you through the format for your letter

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• Review the following:
  • The letter your company received from the FDA: Warning Letter
  • Note: the warning letter has a “typo” which I can’t correct without recreating the original version…you’ll notice the name “Craig Garmendia ” is cut off on the right margin. Please correct to “Craig” as needed.
• Formatting:
  • 2-3 pages
  • Single spaced, 1″ margins, 12-point font

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In the Letter’s Introduction:

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• Acknowledge Primary Investigators (and site’s) obligation to comply with law
• Outline Primary Investigators role in not identifying and preventing the violation(s)
• Outline Primary Investigators role in correcting the violation(s)

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For each violation, include answers to these questions:

• Immediate corrections made (when possible) and how they were documented
• Assess the effect of the deviation on patient health/risks
• Address any systemic ramifications of the violation
• Target date set for ongoing actions such as corrective action plans, timetable for completion, promise to submit documentation