FDA Finalizes Guidance for Generic Drug Manufacturers Seeking Post-Warning Letter Meetings

On June 18, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published a final guidance (the Guidance) addressing the availability of, and process for obtaining, post-warning letter meetings (PWLMs) for generic drug manufacturers.¹ The Guidance finalizes a draft guidance under the same name issued in September 2023. Although there are minor revisions to language, the final guidance is substantively similar to the earlier draft. With issuance of this guidance, FDA fulfills a commitment, made in its Generic Drug User Fee Amendments of 2022 (GDUFA III) Commitment Letter (Commitment Letter), to provide additional information to industry on the process behind PWLM requests.² While intended for generic manufacturers, the guidance also is instructive for any manufacturer seeking a PWLM.  In seeking such meetings, manufacturers of innovator products also should consider additional factors such as the specialized nature of products and potential shortages that make effective and prompt resolution of warning letters more critical.

FDA’s Post-Warning Letter Meeting Request Expectations

The PWLM process is designed to ensure that firms are adequately addressing issues cited in warning letters. PWLM meetings help expedite the reinspection process by setting expectations and ensuring alignment between inspected entities and FDA. The Guidance reiterates the prerequisites for when a firm may seek a PWLM. Specifically, the requesting facility must (1) be in Official Action Indicated (OAI) status and (2) have paid the requisite GDUFA fee for the current year. In addition, the warning letter must be limited to violations arising under the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FDCA),³ including the manufacturing of a drug-device combination product.

The core purpose of a PWLM request is to ensure that firms are enacting corrective and preventive actions (CAPAs) that address FDA’s concerns. Accordingly, meeting requests must include detailed information about proposed and in-progress CAPAs. FDA expects that successful packets supporting a meeting request will include the following:

• a comprehensive CAPA plan with supporting documentation demonstrating how the CAPAs address current good manufacturing practice (cGMP) deficiencies at the facility
• CAPA information organized and presented to map CAPAs to specific warning letter violations
• a complete retrospective review of the issues raised in the warning letter
• projected timelines for CAPA completion
• summaries of all CAPAs resulting from the triggering inspection
• summaries of any relevant CAPAs resulting from prior OAI inspections
• specific questions the firm has for FDA about CAPA adequacy

As the PWLM’s primary purpose is to ensure alignment and facilitate resolution of OAI status, firms should take advantage of the opportunity to obtain FDA’s perspective on remediation but be targeted in the questions they raise to ensure a focused discussion at any resulting meeting.

FDA also expects PWLM requests to contain basic identifying information as well as administrative details. A request packet should provide meeting logistics, including the full list of meeting attendees (including any necessary consultants, interpreters, or counsel as well as any necessary authorization letters), requested dates and times (including unavailable dates), the requested format of the meeting (in-person or remote), and a proposed meeting agenda with estimated time for each topic. Per the Guidance, requests must originate from the facility, parent company, or authorized legal counsel; requests submitted by third-party partners or unaffiliated application holders will not be considered. 

Failure to include any required item in the request packet, or failure to develop and provide supporting information of a robust CAPA plan that addresses all cited items in the warning letter, are grounds for FDA to deny a request. If FDA denies an initial PWLM request, FDA will provide a written explanation for the denial. The company has one more opportunity to request a PWLM; however, the Guidance advises that second requests should be submitted no earlier than three months after the initial request is denied. 

Effectively Requesting and Preparing for a Meeting

The Guidance reiterates that PWLMs typically occur at least six months following the submission of a facility’s initial warning letter response, though firms may request an earlier timeline, and FDA may agree to grant an earlier meeting if the agency determines both parties would benefit from an earlier meeting. 

Firms should ensure there is adequate time for substantial CAPA progress prior to submitting their meeting request. While there is obviously an interest in resolving outstanding issues with FDA as quickly as possible, additional preparation may better position a firm to obtain a meeting in its first outreach rather than rushing to get an unsuccessful request in front of FDA. The Guidance makes clear that if requests are submitted too soon after a firm’s warning letter response, FDA will assume that sufficient progress toward remediation has not been made. 

Coupled with FDA’s imposed three-month delay between a first and second request, firms should consider carefully whether there is a benefit to delaying a meeting request to allow for additional progress on critical CAPAs. If a request is made prior to the six-month timeframe suggested in the Guidance, the request should make clear how both the company and FDA would benefit from an earlier meeting.

Firms must also be sure they have thoroughly evaluated the warning letter issues prior to making a PWLM request. Notably, this includes retrospective assessments or analyses that evaluate the impact of the warning letter items on quality systems and/or marketed product. FDA has expanded its focus on the scope of retrospective impact in recent years, and failure to adequately assess the potential implications of cited issues is specifically called out in the Guidance as grounds for denying a meeting request.

Firms should be aware that FDA requests all information be received well in advance of the meeting. This means that firms should submit a comprehensive request that includes as much documentation as reasonably possible while still taking advantage of the time between request and any granted meeting to update and provide additional information to FDA—particularly on progress made since the request was submitted. While the items detailed in the warning letter should obviously be central to the response, firms also should ensure that they are addressing any other issues identified in the course of the inspection or through their root cause analyses. Demonstrating that continuous improvement efforts are not limited to items specifically raised by regulators is key to convincing FDA of the commitment to thorough remediation.

Implications for Non-Generic Manufacturers

The PWLM program is a welcome pathway for generic manufacturers to seek input from FDA regarding remediation plans well in advance of reinspection. Its origin under FDA’s GDUFA III commitments, however, means that innovator products and manufacturers are not guaranteed the same level of access to the program. Even so, innovator product manufacturers can still request a PWLM and should look to the Guidance as instructive for preparing such requests. Innovator manufacturers may be able to bolster their requests by highlighting factors more typical to their portfolio, such as the specialized nature of products and potential shortages that make effective and prompt resolution of warning letters more critical.  In addition, unlike generics, innovators do not face what may effectively amount to a presumption that most post-warning letter meetings with generics should not occur for at least six months following the warning letter. 

¹ FDA Guidance for Industry, “Post-Warning Letter Meetings Under GDUFA” (June 2025), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/post-warning-letter-meetings-under-gdufa. 

² FDA, GDUFA III Commitment Letter at 36, available at https://www.fda.gov/media/153631/download?attachment.

³ See 21 U.S.C. § 351.