FDA WEBVIEW CLOSED FOR MLK DAY
FDA Webview’s newsroom will be closed Monday (1/18) in observance of Martin Luther King day. Nightly emails will resume 1/19.
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FDA Unveils Transparency Roadmap — Plans More Disclosures
FDA has unveiled a new Transparency Roadmap that calls for expanded public disclosure of complete response letters, clinical study reports, inspection records and other regulatory information as part of a broader fiscal year 2027 transparency initiative. The roadmap builds on FDA’s 2025 initiative to publicly release complete response letters
New CDER Office Focused on AI, Real-World Evidence
CDER has launched a new Office of Innovation and Clinical Trial Modernization (OICTM), including dedicated divisions for artificial intelligence and real-world evidence analytics. The office became operational 10/1 within CDER’s Office of Medical Policy, coinciding with the start of the new federal fiscal year. Its creation was
FDA Flags Evolus Instagram Promotion for Jeuveau
FDA’s Office of Prescription Drug Promotion (OPDP) has cited Evolus over an Instagram promotion for wrinkle treatment Jeuveau (prabotulinumtoxinA-xvfs), saying the post exaggerated the drug's effectiveness and onset of action while minimizing serious risks. OPDP noted that it had raised similar concerns with Evolus in 2019
FDA Urged to Clarify Rare Disease Approval Pathways
FDA’s new commissioner, once confirmed and sworn in, should provide greater clarity on regulatory pathways for rare disease therapies, especially the use of single-arm clinical trials, a rare disease advocate argued in a new Washington Examiner commentary. David Gusick said uncertainty over FDA’s expectations could delay development