Addendum Guideline Evaluation Medicinal Products Indicated Treatment Bacterial Infections
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/addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections
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