Hi everyone,
Hoping to get some input about where others have placed the Safety assurance Case documents (i.e. which eCTD module)? For some high level background, the product is a drug-device combination product (drug led), the device is not a "real" infusion pump it's more of an on-body injector but based on feedback from the agency, a Safety Assurance Case is expected. Since the SAC contains a html file, I'm hoping to get feedback on how this html file was submitted or where it was located in the eCTD.
Thanks in advance!
Sabrina