Want a Steroid-Sparing Claim on Your Label? Start Here
Chronic glucocorticoid exposure, even at low doses, is now seen by regulators and clinicians as an unacceptable safety burden. Sponsors that prioritize steroid-toxicity from the outset position ...
Designing Trials That Capture What Matters: Efficacy, Safety, and Steroid-toxicity
Despite decades of widespread use, steroids are facing a growing backlash. Leading researchers and sponsors are aligning on a new imperative: quantify the harm. A flurry of guidance, tools, and ...
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