Dissolution Discrimination

Simplify Complex Generic – Things to Know About Pre ANDA Meetings (PDEV & PSUB)

July 18, 2025

Purpose of Formal Meetings Between FDA and ANDA Applicant of Complex Generic Products:

To facilitate development of complex products that may be submitted in an ANDA, FDA and industry agreed to different types of meetings between applicants and FDA to discuss the proposed complex product and support submission of a high-quality, approvable ANDA, as well as to provide or continue to provide targeted, robust advice as applicants work to meet the standards for ANDA approval.

Types of Meetings:

A. Product Development Meetings (PDEV)

B. Pre-Submission Meetings (PSUB)

C. Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings

D. Post-CRL Scientific Meetings

In this blog we have discussed some of the most important aspects of PDM and PSM.

	PDEV Meeting	PSUB Meeting
Eligible Products	Complex	Complex with PDEV meeting
When to Request Meeting	No PSG, or new alternative BE method different from PSG recommendation	To present unique or novel data or information that will be included in the ANDA submission
Format of the Meeting	In Person FTF or VC	In Person FTF or VC
Grant/Deny Decision Timeline	14 days	30 days
Days to Conduct the Meeting	120 days from meeting being granted	60 days from meeting request receipt

About Product Development Meetings (PDEV):

Product development meetings are for complex generic products

It's a forum for a scientific exchange on specific issues (e.g., a proposed study design, alternative approach, additional study expectations, or questions), in which FDA agreed to provide targeted advice regarding an ongoing ANDA development program.
General recommendation is no more than one request for a product development meeting for the specific complex product per year.

A product development meeting will be granted if, in FDA’s judgment:

The requested meeting concerns (1) development of a complex generic product for which FDA has not issued a product-specific guidance, or (2) an alternative equivalence evaluation (i.e., change in study type, such as in vitro to clinical) for a complex product for which FDA has issued a product-specific guidance;

FDA determines the prospective ANDA applicant’s meeting package is complete, including any data generated and specific proposals for product development as applicable;
A controlled correspondence response would not adequately address the prospective ANDA applicant’s questions; and
A product development meeting would significantly improve ANDA assessment efficiency (e.g., ultimately decrease the number of review cycles for the application).

FDA may grant a product development meeting, dependent on available resources, if, in FDA’s judgment:

The requested meeting concerns complex development issues other than those identified above (e.g., FDA has developed a product-specific guidance and the prospective ANDA applicant is not proposing an alternative equivalence evaluation);

FDA determines the prospective ANDA applicant’s meeting package is complete, including any data generated and specific proposals for product development (e.g., details regarding the proposed product development plan, such as an alternative study design, and sufficient justification to support the proposal), as applicable;
A controlled correspondence response would not adequately address the prospective ANDA applicant’s questions; and
A product development meeting would significantly improve ANDA assessment efficiency (e.g., ultimately decrease the number of review cycles for the application).

About Pre-Submission Meetings (PSUB):

The pre-submission meeting request will be submitted approximately 6 to 8 months before submission of the ANDA.

The purpose of a pre-submission meeting is to provide a prospective ANDA applicant the opportunity to present unique or novel data or information that will be included in the ANDA submission such as formulation, key studies, justifications, and/or methods used in product development, as well as the interrelationship of the data and information in the ANDA.
The pre-submission meeting does not include substantive assessment of summary data or full study reports, but FDA will identify items or information that should be clarified before submission of the ANDA. The pre-submission meeting is not an opportunity to determine whether the application is acceptable for receipt.
Applicant can request a pre-submission meeting whether or not they had a product development meeting.