FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions

• By: Staff Editor
• Date: February 21, 2017
• Source: https://www.fda.gov

FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions

The process for obtaining approval to market a generic drug varies from the process of gaining authorization to market a novel drug under new drug application. The Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD &C) authorizes an applicant to submit FDA an abbreviated new drug application (ANDA) to seek approval for marketing of the generic drugs.

The FDA has recently issued a draft guidance that clarifies these generic drug manufacturers on how to define and use several terms in ANDA submissions.

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