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



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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GMP Conferences by Topics

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