The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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.

Go back

GMP Conferences by Topics