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The panel recommended that the TGA retain its capacity to undertake complete de novo evaluations and benefit-risk assessments across the entire review spectrum, particularly within the Australian context, including unique population groups, clinical and prescription practices and climatic conditions affecting the supply chain [2, 13]

Reconstituted solutions are generally advised to be stored at low temperature, shielded from light, and used within a defined experimental window to maintain potency and limit microbial risk, in accordance with local lab practices