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Posted On: 07/27/2020 2:55:48 PM
Post# of 36567
Leave it to rjs to find some obscure site that gives the most detail, even better than the FDA site.
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.
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.
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Disclaimer: Of course, all of this is my opinion and you should not make any investment decisions based on my opinion. I have not received any non-public information.
