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We still need larger and longer studies, especially in patients with more active lupus, severe lupus nephritis, and complex autoimmune disease

Register for access to our free webcast: ...or contact us: #pharma #deviceregulatory #riskmanagement #combinationproduct #drugdelivery #FDA #regulatoryaffairs Max Lerman, PhD Sarah Mollo Rob Schulz BlueRidge Life Sciences To view or add a comment, sign in The FDA has taken a step toward greater transparency and efficiency in drug development by publishing the internal filing checklists used by CDER reviewers

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Randomization included assigning a number to each patient using the random number table according to the order of visit