Ensuring ANDA Compliance and Regulatory Alignment
Customer Requirement
A pharmaceutical company with an ongoing ANDA submission required regulatory support to address multiple queries raised by the US FDA during the review process. The agency issued observations across several technical sections of the dossier, with particular emphasis on the Prescribing Information (PI).
Due to limited in-house experience in responding to complex US FDA labelling requirements, the client sought expert regulatory assistance to ensure that all PI-related queries were resolved accurately, consistently, and in line with ANDA expectations, without impacting approval timelines.
Problem Statement
The client faced significant challenges in responding to the US FDA’s PI-related observations:
- Multiple technical queries raised during ANDA review, with heightened scrutiny of the PI section
- Requirements for major PI revisions, increasing regulatory complexity
- Risk of inconsistent alignment between PI content and Module 3 data
- Limited internal capability to interpret and respond to detailed US FDA labelling expectations
- Potential for prolonged review cycles due to unresolved or inadequate responses
Without structured regulatory intervention, the client risked continued agency queries, delayed approval, and increased regulatory exposure.
Key Objective
To resolve US FDA Prescribing Information (PI) queries through accurate regulatory alignment and compliant updates, ensuring ANDA review progression and minimizing the risk of further technical deficiencies.
DDReg Regulatory Support & Outcome
DDReg supported the client by applying regulatory affairs consulting expertise to systematically address all PI-related observations raised by the US FDA. The engagement focused on ensuring that the revised PI fully aligned with agency expectations, regulatory standards, and supporting technical data within the ANDA.
All required updates to the PI were incorporated in a clear and consistent manner, ensuring accuracy, completeness, and regulatory acceptability. The responses enabled effective closure of agency queries and strengthened the overall quality of the submission.
Business Impact
With DDReg’s regulatory support:
- All US FDA PI-related queries were successfully resolved
- Major PI revisions were accepted without further clarification requests
- Alignment between PI and technical dossier content was ensured
- Regulatory communication with the US FDA progressed smoothly
- The risk of additional review cycles due to labelling deficiencies was reduced
Key Learning
US FDA PI reviews demand precision, consistency, and strict alignment with supporting technical data. Addressing agency queries through structured regulatory oversight strengthens submission robustness and supports efficient ANDA review outcomes.
DDReg provides expert support for US FDA ANDA submissions, including Prescribing Information (PI) remediation, query response management, and regulatory alignment ensuring compliance without disruption to approval timelines.
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