The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified under the latest round of the Generic Drug User Fee Amendments (GDUFA III).
The guidance spells out the process for how an eligible facility may request a post-warning letter meeting with FDA, regarding what corrective action the facility is taking to address current good manufacturing practice (cGMP) deficiencies described in the warning letter, how to prepare and submit a complete meeting package and how FDA will conduct the post-warning letter meeting.
The 11-page Post-Warning Letter Meetings Under GDUFA guidance, published Tuesday, specifies that under the GDUFA III commitment letter, spanning fiscal years 2023-2027, a post-warning letter meeting will “generally” occur six months or more after the facility submits an initial response to the FDA warning letter…
