FDA Guidance for Industry: ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions
Title:
FDA Guidance for Industry: ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563507.pdf
Content:
This guidance describes the process through which prospective generic drug applicants submit pre-submission facility correspondence (PFC) in advance of priority3 generic drug submissions.