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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. The Office of Vaccines Research and Review (OVRR) will provide written responses with the possibility of a teleconference if additional clarification is necessary. Because CBER seeks to expedite its response for the development of COVID-19 vaccines, CBER requests that sponsors provide a brief timeline of their clinical/product development plan.