April 2020 FDA ALERT Vaccine Pre-IND Submission
Post# of 36537
Vaccine Pre-IND Submissions
In communications to potential vaccine sponsors interested in meeting to discuss vaccine development for COVID-19/SARS-CoV-2, CBER has requested that potential sponsors submit a pre-IND Written Responses Only (WRO) meeting request and the background package via the Gateway.
https://foleyhoag.com/publications/alerts-and...st-covid19