For my colleagues working on generic drugs the FDA released a final guidance "Facility Readiness: Goal Date Decisions Under GDUFA". The introduction lays out the basic background and impact to applicants and the Agency when planning manufacturing inspections:
"Under the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under the Generic Drug User Fee Amendments of 2017), a goal date was assigned without regard to facility readiness. In the GDUFA III commitment letter, FDA agreed to incorporate facility readiness into goal date assignment, such that FDA generally assigns a 15-month goal date and defers substantive assessment if a facility is not ready for an inspection at the time of application submission. FDA may not be able to complete substantive assessment of an application unless all facilities are ready for inspection. Therefore, this change helps FDA to focus resources on substantially complete applications that contain facilities ready for inspection."
Note that there are exceptions where inspections may still occur as needed (and in some cases, unannounced):
"This guidance does not apply to:
• Facilities involved in bioequivalence and clinical studies used to support an application
• Amendments submitted after a complete response or tentative approval letter
• Supplements or amendments to a supplement"
The remainder of the 9 page guidance provides details for the applicants to assess readiness and inform the Agency, and the Agency's assessment and use of the information.
#fda #SiteInspection #GDUFA
https://www.fda.gov/media/162018/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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