USFDA'S NEW DRAFT REGARDING CVOTS, CARDIO VASCULAR OUT COME TRIALS.

Dear my friends and fellow Colleagues, Here is an update on USFDA new draft regarding CVOTs. USFDA new draft guidance on evaluating safety of new Antidiabetic drugs recommends removal of Cardiovascular Outcome Trials (CVOTs). Instead the draft suggests for Inclusion of >500 patients with CKD stage 3-4 & > 600 patients with Established CVD & 600 patients aged >65 years. March, 2020. Regards and thanks, Dr Sepuri Krishna Mohan.

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