6/7 September 2023
In December 2022, the US-American FDA published the draft of the so-called document "ANDAs: Pre-Submission Facility Correspondence Related to Prioritised Generic Drug Submissions" for comment. This is the second revision of the guidance document, which has been in place since 2017. It is now open for comment until 07 March 2023. It describes how the so-called "pre-submission facility correspondence (PFC)" can be used by generic drug applicants. It can be used in particular for the following three items:
In 2017, the US-American FDA had already published the first revision for comment shortly after the guideline came into force. The new draft now mainly contains changes regarding the timelines, content and assessment of the PFC.
Here you can find the draft version of the "ANDAs: Pre-Submission Facility Correspondence Related to Prioritised Generic Drug Submissions" and further explanations regarding the new draft on the FDA website. Comments can be submitted until the beginning of March 2023.