New FDA Draft Guidance Aims to Eliminate Labeling Headaches for Drug Developers
Submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is no small task. It takes precision, attention to detail, and clear alignment between internal documentation and the product label. But despite best efforts, inconsistencies still happen, especially when it comes to how ingredients are listed.
To address this, the FDA recently released new draft guidance focused on composition statements in labeling. The document offers long-overdue clarification on how to present ingredient information, with the goal of reducing review cycles and helping applications move forward faster.
Here’s a breakdown of what the draft guidance covers and what it means for drug developers.
Aligning Labeling with Application Components
One of the most common issues flagged during FDA review is a mismatch between the label and what’s submitted in Section 3.2.P.1 of the electronic Common Technical Document (eCTD). The new guidance emphasizes the need for both qualitative and quantitative consistency.
In other words, every active and inactive ingredient should appear on the label exactly as it does in the composition statement. That includes hydration state, concentration, and function. Even small discrepancies, like using a range instead of a specific amount without explanation, can cause delays.
Listing Inactive Ingredients with Clarity and Purpose
Inactive ingredients may not affect a drug’s therapeutic action, but they’re critical for formulation and delivery. The FDA now expects applicants to identify these components with greater specificity.
That includes stating the primary function of each inactive ingredient using clear, accepted terminology. Instead of broad categories like “acidifying agent,” applicants are encouraged to use terms like “pH adjuster” or “stabilizer.” Where available, referencing established naming systems such as the Global Substance Registration System (GSRS) or USP–NF titles is also recommended.
Use Real Amounts, Not Prepared Solutions
Another important point: labels must reflect the actual amount of each ingredient in the final product, not the concentration used during manufacturing. For example, if a drug is made using a sodium chloride solution, the label should state the amount of sodium chloride that remains in the product, not just that a saline solution was used. The same applies to any excipient prepared in advance or added via stock solution.
Keep Units Consistent
Uniformity in units of measurement has been a sticking point in many submissions. The new guidance calls for consistent use of units like weight/weight (w/w), weight/volume (w/v), or volume/volume (v/v) throughout the entire application and label.
If conversions are necessary, they should be transparent. That includes sharing the methodology and any relevant supporting data, such as excipient density or calculation assumptions. The goal is to ensure reviewers can trace how you arrived at a given value without confusion or extra clarification.
Nonoral Products Require Full Ingredient Listing
The FDA is also calling for greater transparency in labeling for nonoral dosage forms. Every inactive ingredient, along with its specific amount, should be listed in alphabetical order unless there’s a specific exception, such as isotonicity agents that are referenced by function only. These listings should mirror the composition statement exactly.
Planning for Formulation Variability
For products made at multiple sites or using different manufacturing processes, the draft guidance recommends submitting a parent composition statement. This umbrella document should account for all potential variations in ingredient use, including colorants, preservatives, or excipients added in a range.
Post-approval changes are also addressed. While minor edits can often be reported in annual updates, any substantive revision to the composition or label should go through the appropriate regulatory submission pathway. That might include a supplement or other formal filing, depending on the nature of the change.
A Step Toward Fewer Regulatory Surprises
The FDA’s goal with this draft guidance is to streamline the review process and help drug developers avoid common pitfalls. By ensuring consistency between your submission and your label and documenting ingredient details with clarity and accuracy, you reduce the risk of costly delays and additional review cycles.
For biopharma teams and CROs alike, this is an opportunity to tighten up internal processes and bring greater alignment between regulatory submissions and public-facing documentation. To view the full draft guidance, click here. We’ll be keeping an eye out for the finalized version and will continue to share updates as they become available.
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For many teams, navigating updates like this is just one part of an already demanding workload.
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