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COVER SHEET for 8500 8 ADDITIONAL INFORMATION Faa

COVER SHEET for 8500 8 ADDITIONAL INFORMATION Faa

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hello my name is lieutenant commander cassandra metoo and i'm a senior regulatory project manager in the office of generic drugs at the food and drug administration and i have one of the most important presentations that you are going to experience during this conference and that is the information to include with your cover letter i do have some learning objectives for this presentation first to understand the purpose of the cover letter to examine that fda issued guidances also to evaluate what information is most important to include in the cover letter and lastly to understand the resources that you guys can use to create an effective cover letter for your submission purpose so what is the purpose of a cover letter the primary purpose of a cover letter is to summarize the content identify the purpose of the submission highlight key elements and also provide required regulatory statements but for the fda one of the most important purposes of the cover letter is to help the f

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