“Every label difference found before FDA finds it.”

LabelGuard reads your proposed generic drug label and the Reference Listed Drug label side by side — performing a precise, section-by-section comparison that identifies every difference in Boxed Warnings, indications, dosage instructions, contraindications, adverse reactions, and patient information. Each deviation is annotated with the applicable FDA labeling regulation so your regulatory team knows exactly what to correct before the submission reaches the health authority.

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Agent Details

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IndustryPharma

Output typeAnnotated deviation report

Data isolation✓ 6 layers

Audit trail✓ Immutable

This agent produces finished work ready for your team’s review and approval. It completes entire workflows — not just suggestions or partial answers.

Features

What LabelGuard does.

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Section-by-section label comparison

Aligns and compares every section of the proposed label against the Reference Listed Drug label — Boxed Warnings, Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interactions, and Patient Counseling Information — in the correct FDA label structure.

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21 CFR regulation annotation

Each detected deviation is annotated with the specific 21 CFR Part 201 labeling regulation and current FDA labeling guidance that governs that section — giving your regulatory team the exact compliance context needed to correct or justify each difference.

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Deviation severity classification

Classifies each difference as Critical — likely to cause Refuse-to-File — Major — likely to generate an information request — or Minor — editorial in nature — so your team prioritises review effort on the issues that matter most.

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Formatted annotation report output

Produces a formatted deviation report showing the RLD text, your proposed text, the highlighted difference, the severity classification, and the regulatory citation for every finding — suitable for inclusion in the ANDA submission package.

Advantages

Why it matters to your team.

The real operational benefits your team will experience — described in terms of the work you will no longer have to do, and the outcomes you will achieve instead.

Label-related Complete Response Letters prevented

Label discrepancies that do not comply with FDA requirements are among the most common causes of CRLs in ANDA reviews. LabelGuard catches them before submission — turning a months-long CRL remediation cycle into a pre-submission correction that takes days.

Two to three days of manual review time eliminated per submission

Experienced regulatory staff currently spend two to three days manually comparing labels section by section. LabelGuard completes the same analysis in minutes — freeing your team for the scientific judgement the output requires.

Consistent compliance standard across your ANDA portfolio

For companies managing multiple ANDAs simultaneously, LabelGuard applies the same rigorous check to every proposed label — eliminating quality variation from manual review under competing time pressures.

Post-approval label supplements handled automatically

LabelGuard handles label supplements, CBE-0 changes, and post-market safety updates — not just initial ANDA submissions. The comparison report it produces can be included directly in the supplement package as the FDA-required change documentation.