FDA expects to release its qualified health claims proposed rule this fall, pending review of public comments and agency-sponsored label comprehension research
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
