Resolving US FDA Prescribing Information (PI) Deficiencies During ANDA Review

 

During the evaluation of an Abbreviated New Drug Application (ANDA), the US FDA issued a series of review comments covering multiple sections of the submission. A substantial portion of these comments focused on Prescribing Information (PI), reflecting the agency’s heightened expectations for labeling accuracy, internal consistency, and traceability to supporting data.

Recognizing the regulatory sensitivity of PI deficiencies and the potential impact on approval timelines, the applicant engaged external regulatory expertise to manage and resolve the observations in a structured and compliant manner.

Client Need

The applicant required specialized regulatory support to:

• Interpret and respond to complex US FDA PI-related observations
• Execute extensive revisions to the Prescribing Information
• Maintain consistency between PI statements and underlying ANDA data
• Avoid further rounds of FDA queries or review delays
• The priority was to achieve first-cycle closure of PI deficiencies without introducing new regulatory risk.

Regulatory Challenges Identified

Several critical issues were identified during assessment:

• Multiple FDA observations with concentrated focus on labeling content
• Requirement for substantive PI amendments rather than minor editorial changes
• Risk of divergence between PI language and Module 3 technical justifications
• Limited internal exposure to advanced US FDA labeling expectations
• Increased likelihood of extended review timelines if responses lacked precision
• Without a coordinated regulatory strategy, the ANDA faced the risk of repeated information requests and prolonged agency engagement.

Objective

To deliver a fully compliant, FDA-aligned Prescribing Information package that addressed all agency observations, supported by consistent technical data, enabling smooth continuation of the ANDA review.

Regulatory Approach

DDReg implemented a systematic resolution strategy grounded in US FDA labeling guidance and ANDA regulatory practice. Key activities included:

• Comprehensive gap analysis of FDA PI comments against submitted labeling
• Scientific and regulatory reconciliation of PI content with ANDA source data
• Controlled revision of PI sections to meet FDA clarity, accuracy, and formatting expectations
• Development of clear, defensible responses to ensure effective query closure
• Each update was reviewed for regulatory coherence to prevent downstream inconsistencies across the dossier.

Results Achieved

• Successful closure of all PI-related FDA observations
• Acceptance of revised Prescribing Information without additional follow-up questions
• Improved internal consistency between labeling and technical submission content
• Streamlined FDA communication during the ongoing review
• Reduced probability of additional review cycles linked to labeling deficiencies

Impact

The structured regulatory intervention strengthened submission quality, minimized regulatory back-and-forth, and supported uninterrupted ANDA review progression. The client mitigated approval risk while meeting US FDA expectations for labeling compliance.

Key Insight

Prescribing Information deficiencies are a frequent cause of ANDA delays. Proactive regulatory interpretation, disciplined content alignment, and structured response development are essential to achieving efficient FDA review outcomes.

DDReg supports pharmaceutical companies throughout the US FDA ANDA lifecycle, offering expert services in Prescribing Information remediation, FDA query management, and regulatory alignment to ensure compliance without approval delays.

Explore more DDReg case studies: https://resource.ddregpharma.com/case-studies/us-fda-prescribing-information-pi-query-resolution/