FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions

  • By: Staff Editor
  • Date: February 22, 2017
  • Source:
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FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions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The FDA has recently issued a draft guidance that clarifies these generic drug manufacturers on how to define and use several terms in ANDA submissions.

Related Training:

An Introduction to the FDA New Drug Approval Process

FDA Guidance Focus Areas

The FDA draft guidance assists applicants in identifying reference listed drug (RLD), reference standard, and the basis of submission in an ANDA. The key areas focused in this guidance are:

  • Reference Listed Drugs (RLDs) definition including FDA’s identification of listed drugs that have been designated as RLDs, choosing an RLD, and the role of RLD in an ANDA submission.
  • Reference standard definition including its selection and requesting selection of a reference standard.
  • Basis of submission for an ANDA for a generic drug that is same as its RLD including:
    • for first petitioned ANDA
    • for a generic drug that is the same as a drug product approved in a petitioned ANDA

The guidance document further clarifies the differences among the terms RLD, reference standard and basis of submission to ensure adherence to the ANDA submission requirements.

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