Earlier today (03 October 2022) USFDA released two finalized guidelines "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA" and "Facility Readiness: Goal Date Decisions Under GDUFA".
Generic Drug User Fee Amendment (GDUFA): is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to the industry.
GDUFA must be reauthorized every 5 years and this user fee program has been reauthorized two times since GDUFA I.
Guidance on: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
The purpose of this guidance is to provide guidance to the holders of Type II API drug master files (DMFs) that will be used in an abbreviated new drug application (ANDA) or an ANDA prior approval supplement (PAS).
According to the guidance, DMF holders can request an early assessment, or "DMF prior assessment," and FDA will conduct an early assessment of API DMFs six months before an ANDA or PAS submission references the DMF.
Guidance on: Facility Readiness: Goal Date Decisions Under GDUFA
What is Goal Date?
During the initial 15-month review period, if the applicant submits an amendment with a Form FDA 356h that certifies all facilities are ready for inspection, FDA will set a date that is 8 months from the date of submission for priority amendments (if a Pre-Submission Facility Correspondence was submitted) or 10 months from the date of submission for other amendments which is called the Goal date.
This guidance explains how FDA incorporates program enhancements agreed upon by the Agency and industry in negotiations surrounding the reauthorization of GDUFA.
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