DDReg Pharma

DDReg Pharma

Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated product development.

Types of Pre-ANDA Scientific Meetings

There are various pre-ANDA scientific meetings under that the applicants may request. There are 2 types of Pre-ANDA Scientific Meetings: Product Development (PDEV) Meetings and Pre-Submission (PSUB) Meetings. Under the GDUFA III, PSUB meetings have faced some changes with respect to the scope and timelines.

Additional Pre-ANDA Scientific Meetings that do not fall under the GDUFA III include the FDA-EMA Parallel Scientific Advise (PSA) Pilor Program- for complex generic/hybrid products and the Model-Integrated Evidence (MIE) Industry Meeting Pilot.

The PDEV, MIE, and PSA meetings are scientific exchanges between the applicant and the US FDA to discuss specific issues or questions and obtain targeted/specific advice regarding ongoing ANDA development programs. Typically, applicants are recommended to utilize question-based meetings, such as PDEV, MIE, or PSA, to obtain feedback from the US FDA regarding ongoing generic product development programs. Then, they may use the PSUB meeting to orient ANDA assessors to unique or novel data or information in the prospective ANDA before submitting the ANDA.

What does the Redesigned PSUB Meeting allow?

PSUB meetings with the US FDA allow prospective applicants to present “novel” or “unique” data to be including in the ANDA submission i.e., formulation, key studies, justifications, methods used in product development, etc. It is important to note that a PSUB meeting is not meant for substantive assessment of summary data or full study reports, nor is it an opportunity to determined whether ANDAs are acceptable for receipt.

The US FDA will grant applicants a PSUB if the applicant was already granted a PDEV meeting for the same complex generic product, and also if the US FDA believes that a PSUB meeting may help improve the efficiency of the assessment.

What should the PSUB Meeting Package include?

Applicants are required to refer to the “Formal Meetings between FDA and ANDA Applicants of Complex Products Under GDUFA” and should provide high level of information. Applicants must not include any questions. The meeting package should include data on if there were any prior PDEV meetings for the same proposed complex generic product (event IDs for prior PDEV meetings and summary of any advice from the PDEV meeting). If no prior PDEV meeting was held then the applicant must provide an explanation or justification for why a PSUB meeting should be granted including the estimated timeline for ANDA submission and unique/novel information to be included in the ANDA submission. The suggested presentation template for a PSUB meeting package is included in Appendix B of the Formal Meetings Guidance document.

PSUB Meeting Timeline

Once the PSUB meeting request has been submitted, the US FDA has 30 days to provide a “grant” or “deny” letter to the applicant for their meeting request. Typically, the meeting is held within 60 days of the FDA receipt date where the Agency may come back with preliminary comments more than 5 days before the meeting date. The meeting minutes are issued within 30 days of the meeting date and applicants may submit summary of meeting discussions within 7 days of the meeting date.

Applicants are recommended to submit PSUB meeting requests 6-8 months before ANDA submission.

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DDReg has provided its customers with regulatory services for the USA and support in facilitating meetings with the US FDA including pre-IND, pre-ANDA, Post-Warning Letters and more. Reach out to DDReg for expert and tailored guidance to submit meeting requests with the US FDA. Read more about meetings with the US FDA: Requesting Post-Warning Letter Meetings