FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.
CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.
CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.
FDA posts a final guidance entitled “Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH).”
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.
