ANDA Pre-Submission Facility Correspondence Guidance

FDA has posted a draft guidance entitled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” The document addresses generic drug user fee program enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC). Under the latest user fee commitment letter, FDA says it has agreed to performance goals and program enhancements designed to maximize the efficiency and utility of each assessment cycle, such as the facility assessment. Specifically, the guidance describes:

• the content and format of the facility information that should be submitted to enable FDA’s assessment of facilities listed in the PFC;
• timeframes for the PFC, and the intersection of these timeframes with submission of an ANDA;
• the possible outcomes of an agency assessment;
• and, when and how the agency communicates with an applicant about receipt of the PFC and assignment of a goal date for the ANDA.