For the midterm essay exam, you will be required to analyze this FDA warning letter. You should include all of the following elements in your essay:1. Case AnalysisProvide a brief analysis/summary2. P

For the midterm essay exam, you will be required to analyze this FDA warning letter. You should include all of the following elements in your essay:

1. Case Analysis

Provide a brief analysis/summary

2. Problem(s)

Identify the problem(s)/issue(s)

3. Solution(s) and Recommendation(s)

Provide a solution(s) for the identified problem(s)/issue(s). What would you recommend as an RA professional?

4. Conclusion

Provide a conclusion as follows:

· As an RA professional what lesson (s) am I learning from this incident?

· How will this information help me in the future?

In addition, your essay should be prepared, formatted and submitted as detailed below:

Format: Essay–APA style

Length: 4–6 pages

Description: Double-spaced, 12-point Times New Roman font

Expectations: Prepare your analysis in Word and submit it to the Week 6 assignment folder in the Assignments area

This is a graduate class called the practical application of biotech regulatory affairs, this class is about FDA regulations when it comes to drug products.

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