FDA new draft guidance: Post-warning letter meetings under GDUFA

The US Food and Drug Administration (FDA) on Friday announced a draft guidance for industry, “ Post-Warning Letter Meetings Under GDUFA.”

The guidance provides information on the implementation of the post-warning letter meeting process for certain drug manufacturing facilities, 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), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” ( GDUFA III commitment letter).

Specifically, this draft guidance describes: