Submitting Documents Using Real World Data AND Real World Evidence FDA Drugs AND Biological Products Guidance Industry
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biological-products-guidance-industry
Rules Mate indexes Australian government compliance resources to make them searchable. We link to + summarise; always verify the live source before acting.