Sponsor / FDA Meetings 

B&H has coordinated and participated in more than 125 formal face-to-face and teleconference meetings, as well as informal teleconferences with FDA. The types of meetings are as follows:

  • Type A:                                      5%
  • Type B:
    • Pre‑IND:                          20%
    • End‑of‑Phase 2:              20%
    • Pre‑NDA:                        20%
    • Type C Guidance:            25%
    • Informal Teleconference:   10%


 

 

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