USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA" which provides recommendations to the industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

This guidance is pivotal for applicants seeking to understand the FDA’s expectations and requirements for generic drug development, particularly about PSGs. This guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated by the Generic Drug User Fee Amendments (GDUFA III commitment letter).

Moreover, these procedures help ensure that PSG meetings are scheduled and conducted in accordance with the time frame specified in the GDUFA III commitment letter, which promotes well-managed PSG meetings.

The guidance provides detailed instructions on how to request different types of PSG meetings, each serving a different stage of the ANDA application process:

• A. PSG Teleconferences: These are informal meetings conducted over the phone or through other telecommunication methods. They are split into two categories:

  1. Pre-Submission PSG Teleconferences: These are intended for discussions before the ANDA submission, where the FDA provides feedback on the applicant’s proposed studies and development plans.

  2. Post-Submission PSG Teleconferences: These are conducted after the ANDA submission to discuss any issues or additional requirements identified by the FDA during the review process.

• B. Pre-Submission PSG Meetings: These are more formal than teleconferences and involve face-to-face or virtual meetings to discuss the development strategies before the ANDA submission.

• C. Post-Submission PSG Meetings: Similar to Pre-Submission PSG Meetings but conducted after the ANDA has been submitted, focusing on resolving any outstanding issues that could delay approval.

The guidance outlines the performance goals under GDUFA III, which include timely scheduling and conduct of meetings, prompt feedback, and ensuring that meetings are productive and aligned with the FDA’s overall goal of facilitating generic drug approvals. Also covering aspects such as introductions, agenda setting, and the conduct of discussions.

Applicants can request to reschedule or cancel meetings under certain conditions, with detailed procedures provided for each scenario. If there is a disagreement about the content of the meeting minutes, the guidance outlines the process for resolving such disputes.

For more detailed information, please refer to the official US FDA guidance.