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Key Points
Audio Transcript
The FDA has created a decision tree to help guide you through the approval process. We will walk step-by-step through the tree to understand how a given approval pathway leads to obtaining approval for a drug. Notice, the tree has three major branches: one to help you determine if an ANDA is required, one for determining if the drug should seek an OTC Monograph, and another for carrying you through the NDA process.
The OTC pathway is depicted in the middle yellow column and the bottom left yellow diamond and oval of the decision tree.
This decision tree presents you with an overview on how marketed unapproved drugs may comply with requirements under the Federal Food, Drug, and Cosmetic Act. Use this decision tree as a guide through the steps needed to legally market a product within the United States. Note that with any particular drug product, there may be variations and additional relevant factors. For instance, when a drug contains more than one active ingredient, each ingredient, as well as the combination as a whole, will need to be addressed. Additional resources are provided for you in the 'Resources' tab of this module.