The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to help industry increase the quality and suitability of electronic common technical document (eCTD) submissions by identifying the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA. In turn, it will help the FDA meet its obligations under the Generic Drug User Fee Act (GDUFA), which requires the agency to approve an ever-increasing number of ANDA submissions within ten months of submission.
The guidance details the necessary information to be provided in each section of the CTD for human pharmaceutical product applications. The guidance also identifies supporting guidance documents and recommendations issued by FDA to further assist applicants in preparing their ANDA submission. In the past, FDA has published guidance on refuse-to-receive (RTR) standards, and common, recurring deficiencies. These should be reviewed thoroughly prior to submission of an ANDA.
Key points from FDA’s new ANDA submissions guidance
- Ensure Module 1 includes a completed, signed Form FDA 3674, Certification of Compliance.
- For Module 1, also Include a U.S. agent letter of appointment, if applicable. (Click here for the U.S. Agent functions Synchrogenix performs)
- Module 1 must also include the field copy certification.
- Be sure to also include the debarment certification, required under GDUFA.
- We encourage you to review and utilize the Question-Based Review (QbR) model when developing labels and writing summaries. Responses to the QbR should be provided in section
188.8.131.52, as applicable.
- Submit the Quality Overall Summary (QOS) and prescribing information as an MS Word and text-based PDF file.
- Use an eCTD Study Tagging File for each clinical study submitted.
- Module 5 for Clinical Study Reports must contain the complete study data for the biopharmaceutic studies and the lot numbers and strength of the products.
- FDA recommends that literature references be provided in searchable text-based PDF files.
The above list is only a representative sample. Please refer to the guidance for more information.
Synchrogenix’s regulatory publishing team has over ten years’ experience preparing and submitting ANDAs and other electronic regulatory submissions. Please visit our website or contact us today to learn more about how we can help guide your organization through submissions.