(Total Views: 373)
Posted On: 10/10/2018 1:49:56 PM
Post# of 72440
The FDA will respond in 14 days for Type B (EOP) meeting request (page 8, table 1). The actual meeting will be scheduled in 70 days (table 2). With Fast Track and possibly BTD, it could be sooner.
https://www.fda.gov/downloads/Drugs/GuidanceC...590547.pdf
https://www.fda.gov/downloads/Drugs/GuidanceC...590547.pdf
(4)
(0)
Scroll down for more posts ▼