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Hi,
We submitted a new trial application with COFEPRIS. Doing some scenario planning: in the event our application receives observations, what are next steps?
- If we need to amend study documents (eg, protocol, IB) how much time are we given to submit these updated documents?
- Are we required to have the ethics committee review the updated documents before submitting to COFEPRIS?
- What is the usual review timeframe for responses?
Any input would be greatly appreciated. Having a hard time finding information online. Thank you!