FDA Guidance for Industry: ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions

Titel:
FDA Guidance for Industry: ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563507.pdf

Inhalt:
This guidance describes the process through which prospective generic drug applicants submit pre-submission facility correspondence (PFC) in advance of priority3 generic drug submissions.

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