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USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling

Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs." This guidance is designed to help applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submit accurate and comprehensive applications. It provides best practices for writing composition statements and corresponding statements of ingredients in the labeling, when applicable.

The guidance includes examples of common issues identified by FDA during its assessment of NDAs and ANDAs regarding the composition statement and provides applicants with suggestions on how to avoid these problems.

This guidance also describes FDA’s intent, when possible, to use the composition statement submitted in electronic common technical document (eCTD) section 3.2.P.1 of NDAs and ANDAs as the statement of ingredients.

It suggests ways to reduce the number of review cycles and communications needed for approval, as well as ensuring that FDA-approved labeling contains the required qualitative (Q1) and quantitative (Q2) ingredient information.

Certain drug products, such as those administered parenterally, ophthalmically, or otically, must have identical inactive ingredients (Q1 sameness) at the same concentrations (Q2 sameness), with some exceptions. This requirement ensures that the inactive ingredients do not impact the safety or effectiveness of the drug product. In some cases, the bioequivalence of a drug product may be considered self-evident if it contains the same inactive ingredients in the same concentrations as a drug product covered by an approved NDA or ANDA.

Additionally, ANDAs must contain information to show that the proposed labeling for the generic drug product is the same as the labeling for the RLD, with certain permissible differences. For FDA to efficiently evaluate whether ANDAs meet these requirements, it is crucial for NDA and ANDA applicants to clearly and accurately report their inactive ingredients. Failure to do so can result in longer assessment times, more assessment cycles, and increased FDA communication with applicants. Accurate identification of inactive ingredients is also critical for determining if they could impact the drug product's safety or effectiveness.

Click this LINK to know more about the Consistency Between the Composition Statement in NDAs and ANDAs and the Statement of Ingredients in the Approved Labeling and many more sections in detail.


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