FDA: Updated ANDA PFC Document Published for Comment

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

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:

• ANDA (Abbreviated New Drug Application)
• PAS (Prior Approval Supplement)
• Or supplements to the two processes mentioned above.

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.