What is an FDA Post-Warning Letter Meeting?

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The U.S. Food and Drug Administration (FDA) issues Warning Letters to companies or individuals when it believes there are violations of federal law related to the safety and effectiveness of drugs, medical devices, or other products within its regulatory purview. Most of these are issued following an inspection. When reading FDA Warning Letters, you might have recognised that under the program enhancements for the Generic Drug User Fee Amendments (GDUFA or GDUFA III Commitment Letter), the facility may be eligible for a so-called Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of the company's corrective action plans.

A Post-Warning Letter Meeting refers to a meeting that can take place between the FDA and the recipient of a Warning Letter after the letter has been issued. The purpose of such a meeting is typically to discuss issues raised in the Warning Letter, address open concerns outlined by the FDA, and establish a path forward for corrective actions. So, the company has the opportunity to present their perspective, provide additional information, and discuss corrective action plans.

It is a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA). The procedure for requesting an eligible Post-Warning Letter Meeting is also described here.

The number of pharmaceutical companies that take advantage of Post-Warning Letter Meetings with the FDA can vary.