Meeting with the FDA to discuss your development plans can help reduce both costs and time to approval. The FDA has issued formal guidance on this entire process, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry.
To meet with the FDA, you will need to decide on your preferred format for the meeting (face-to-face, teleconference, or written responses), and submit a formal meeting request accompanied with or followed closely by an informational package. Once the FDA has reviewed your meeting request, they will determine whether to grant the meeting and determine the meeting format.
View our FDA Meeting Types Infographic to learn about Type A, Type B and Type C meetings – with specific insights into meeting timing, purposes and examples of each type throughout development. View the infographic to learn more.