Formal Meetings Between the FDA and Sponsors or Applicants of Pdufa Products - Guidance for Industry is a 20-page legal document that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on December 1, 2017 and used nation-wide.
Q: What does PDUFA stand for?
A: PDUFA stands for Prescription Drug User Fee Act.
Q: What is the purpose of the FDA meetings with sponsors or applicants of PDUFA products?
A: The purpose is to facilitate discussions and provide guidance related to PDUFA products.
Q: Who does this guidance apply to?
A: This guidance applies to industry sponsors or applicants of PDUFA products.
Q: What is the goal of these meetings?
A: The goal is to improve the efficiency and effectiveness of the drug development and review process.
Q: What topics can be discussed in these meetings?
A: Topics may include pre-investigational new drug application, pre-new drug application, and end-of-phase 2A meetings, among others.
Q: How can a sponsor or applicant request a meeting with the FDA?
A: They must submit a meeting request to the appropriate FDA review division.
Q: Are these meetings mandatory?
A: No, these meetings are not mandatory, but they can be beneficial for both sponsors/applicants and the FDA.
Q: Is there a specific format for these meetings?
A: No, the format can vary depending on the goals and needs of the meeting.
Q: Are there fees associated with these meetings?
A: Yes, there are fees associated with certain types of meetings, as outlined in the PDUFA fee schedule.
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