Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.
FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods used to evaluate bi...
A new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healthcare.
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly repo...
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improve...
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in Decem...
