Key Steps to Minimize the Chances of Getting a RTR from FDA

I am reaching out today to share important information that can help us circumvent any potential issues with Abbreviated New Drug Applications (ANDAs) filed with the FDA.

ANDAs are essential for the marketing of generic drugs, and therefore receiving a Refusal to Receive (RTR) can significantly delay approvals.

From detailed research and from my diverse experience, I have identified some key steps to minimize the chances of getting a RTR but not limited to:

Ensure Full Completeness of your Application: Incomplete applications are a common reason for refusals. Be sure that all required forms, documents, and studies are hitherto submitted in eCTD format to prevent any discrepancies.
Compliance with cGMP regulations: Companies must always comply with the FDA’s current good manufacturing practice (cGMP) regulations to ensure that their products consistently meet the agency’s quality standards. All facilities listed in the application should have cGMP compliance.
Preparation of Quality Control/Analytical Data: Maintaining well-prepared and thorough quality control analytical data will facilitate the FDA’s ability to review your application, mitigating the risk of a RTR.
Effectively Communicate with the FDA: Maintain communication with the FDA throughout the development and review process. Make use of Pre-ANDA meetings to address potential issues before filing.
Understand and Respect Formatting Requirements: Incorrect formatting can lead to a RTF. Ensure you are familiar and compliant with the FDA’s formatting rules for electronic submissions.

The onus of ensuring the completeness, accuracy, and timeliness of your submissions lies with us. It’s highly crucial that our teams are well-aware of the common pitfalls and also abreast with the latest FDA guidelines to reduce the potential for receiving a RTR.

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Resource Person: Dr Isha Talwar

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