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Update - Changes to the eFiles submission form requirements
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Hello @manufacturer @agency
Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.
What's changing?
PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.Click here to more about why, new form requirements, and what this means for the review process.
Question? Post below and we'll get back to you.
Thanks
PAAB
