Pre-submission facility correspondence for generic dosage form with an expedited-approval in 8 months

Abstract

PFC (Pre-Submission Facility Correspondence) is the initial submission for an ANDA (Abbreviated New Drug Application), comprising information for the application similar to the original ANDA, and only valid in the United States Agency For a pre-determined inspection of the finished drug product's facility information. The Applicant can be introducing their Drug Product into the Market before the ANDA's Goal date of 8 months, according to the Pre-Submission Facility Correspondence. The submission type Original ANDA, PAS (Prior approval supplement), and PAS Amendment is based on prior review goal submission. The FDA (Food and Drug Administration) approves PFC submission for a range of reasons, including drug product shortfalls, COVID-19 emergency dosage medication, Patent paragraph-IV (patent is invalid or will not be infringed), and market-availability of one RLD (Reference listed drug) and one generic. The complete submission process gone through the eCTD submission format from the ESG (Electronic Submission Gateway).