Small Business Assistance
Center for Drug Evaluation and Research
Human Drug Establishment Registration and Drug Listing Compliance
Who Must Register and List
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Module Review

Congratulations! You have completed the "Who Must Register and List" module.

Let's take a minute to review the key points about what you have learned.

In this module we received detailed insight into answering the three fundamental questions a firm should ask when assessing whether they should register and list:

  1. Is the product a human drug?
  2. Does the firm participate in the manufacture or processing of the drug?
  3. Does the drug enter into U.S. commercial distribution after being manufactured or processed?
To continue this course, move on to the next module entitled, "When to Register and List."

FDA Representative holding a sign saying "Module Review."
USER INSTRUCTIONS:

Click HOME to review the lessons in this module.
Click MENU to return to the Course Menu.
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