Reshma Ramachandran

Associations between methodological quality and representation in clinical trials of systemic lupus erythematosus therapies

Background Randomized clinical trials support drug development and uptake of new therapies for systemic lupus erythematosus (SLE). However, challenges to conducting high-quality clinical trials have been noted, including underrepresentation of minoritized populations. Currently,...

US Food and Drug Administration Officials’ Public Statements on Regulatory Flexibility in New Drug Approval, 2021–2024

The US Food and Drug Administration (FDA) has historically exercised substantial regulatory flexibility to adjust the type, amount, and quality of evidence necessary to support drug approval for areas of unmet need. Our objective was to characterize how FDA officials described an...