The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Compliance has implemented a new meeting for generic drug manufacturers that have received CGMP warning letters, offering a new avenue for a facility to obtain feedback on its remediation of warning letter deficiencies.
As part of user fee negotiations under the Generic Drug User Fee Amendments (GDUFA), which occur approximately every five years, the FDA commits to performance goals in reviewing ANDAs as well as other program enhancements. Under the most recent performance goals and program enhancements for GDUFA reauthorization for fiscal years 2023-2027—known as the GDUFA III Commitment Letter—the Agency agreed to the implementation of a Post-Warning Letter Meeting (PWLM), a program enhancement that offers generic drug manufacturers an opportunity to request feedback from the FDA regarding a facility’s ongoing remediation efforts to address CGMP deficiencies that were the subject of a warning letter.
On June 20, 2025, the FDA published a final guidance for industry on this topic, Post-Warning Letter Meetings Under GDUFA. This guidance finalized a draft guidance initially published on September 5, 2023.
New FDA Touchpoint
In contrast to a regulatory meeting requested by the FDA in response to an Official Action Indicated (OAI) determination issued after completion of a problematic inspection (typically used as an “effective enforcement tool” to inform a firm about how its products, practices, processes, or other activities are considered to be in violation of the law), a PWLM is an optional meeting requested by a firm to obtain the Agency’s preliminary feedback on the adequacy and completeness of a facility’s corrective action plans—a new touchpoint with the Agency for feedback on CAPAs. (For additional information, please see Chapter 10 of FDA’s Regulatory Procedure Manual here and Section VII.D. of the GDUFA III Commitment Letter here.)
A generic drug manufacturer may be eligible to request a PWLM if its manufacturing facility’s CGMP compliance status is classified as OAI as a result of an FDA inspection and the facility has paid its GDUFA facility fees and been issued a warning letter with adulteration violations and/or deviations from 21 U.S.C. § 351 of the Federal Food, Drug, and Cosmetic Act.
Notably, the FDA has also begun to “recommend,” in warning letters, that firms request PWLMs after their initial responses.
Requesting a PWLM
As discussed in the new final guidance, the FDA only intends to grant a PWLM if “reasonable progress” has been made toward the deficiencies cited in a warning letter, and the Agency will view that reasonable progress is “unlikely” if a PWLM request is submitted shortly after issuance of the warning letter. To emphasize, the Agency notes in the guidance that a PWLM will generally take place six months or later, after a firm’s initial response to a warning letter.
Accordingly, a request for a PWLM should include not only a CAPA plan but sufficient information to show that reasonable progress has been made toward remediation. In addition, the Agency requests that the meeting request include a description of the root-cause analysis and a retrospective evaluation of the impact of the violation/deviation on product quality and other systems for each warning letter violation/deviation.
Lachman has vast expert regulatory compliance experience (including a significant number of ex-regulators who have experience with PWLM). Reach out to us today for a consultation at LCS@LachmanConsultants.com if you would like to request and prepare for a Post-Warning Letter Meeting with the FDA.
