2021 Clinic Management Labelling 
IDStewardship
JUNE 19, 2025
Despite advancements in treatment, certain patients may exhibit delayed responses, have drug-resistant TB, be at risk for drug-drug interactions, or have comorbid conditions that considerably complicate clinical management. N Engl J Med 2021; 384: 1705–1718. CDC for treating pulmonary tuberculosis 23.
ISPE
OCTOBER 27, 2022
In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Published 9 July 2021. Updated 29 November 2021. Published 22 December 2021.
ISPE
OCTOBER 27, 2022
In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Published 9 July 2021. Updated 30 August 2021. IMDRF SaMD Risk Categorization. Gilbert, A.
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