BTRA 642 UM Biology Food and Drug Administration Paper

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For the final, submit a 3-4 page double spaced comments on an FDA draft guidance. 

You can select a draft guidance by searching the guidance database ( and filtering on your choice of agency (CBER, CDER, or CDRH).

In your comments, state any issues or challenges  you anticipate for the industry with the proposed guidance, and suggest improvements. 

Explain why you chose this specific guidance, and how does it affect your operations (can be theoretical or real-life example).

Follow the format as comments submitted to FDA (

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