Formal Meetings Between the FDA and Sponsors or Applicants of Pdufa Products - Guidance for Industry

Formal Meetings Between the FDA and Sponsors or Applicants of Pdufa Products - Guidance for Industry is a 16-page legal document that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on March 1, 2015 and used nation-wide.

FAQ

Q: What is the FDA?
A: The FDA is the Food and Drug Administration, a government agency responsible for regulating and approving drugs and medical products in the United States.

Q: What are PDUFA products?
A: PDUFA products refer to drugs and medical products that are subject to the Prescription DrugUser Fee Act (PDUFA), which requires payment of fees by manufacturers to support FDA's drug review process.

Q: What is the purpose of formal meetings between the FDA and sponsors or applicants of PDUFA products?
A: The purpose is to provide a platform for communication and discussion between the FDA and the companies developing or seeking approval for PDUFA products.

Q: Who can participate in these meetings?
A: Sponsors or applicants of PDUFA products, such as drug manufacturers or medical device companies, can participate in these meetings.

Q: What are the different types of formal meetings mentioned in the guidance?
A: The guidance mentions three types of formal meetings: Type A, Type B, and Type C meetings.

Q: What is a Type A meeting?
A: A Type A meeting is a meeting requested by the sponsor or applicant for the purpose of discussing an issue that is delaying the review or approval of a PDUFA product.

Q: What is a Type B meeting?
A: A Type B meeting is a meeting requested by the sponsor or applicant to discuss certain topics, such as pre-investigational new drug application (pre-IND) meetings or end-of-phase 1 meetings.

Q: What is a Type C meeting?
A: A Type C meeting is a meeting requested by the FDA to discuss a specific topic that does not fit the criteria for Type A or Type B meetings.

Q: What is the process for requesting a formal meeting?
A: The guidance provides details on the process for requesting a formal meeting, including the required documentation and timelines.

Q: Are these formal meetings mandatory?
A: No, these meetings are not mandatory, but they can be beneficial for both the FDA and the sponsors or applicants of PDUFA products to address potential issues or concerns.