Post by Lily Li-Wen Wang, Ph.D.

📣𝐓𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐌𝐚𝐫𝐜𝐡 𝟐𝟎𝟐𝟔 𝐝𝐫𝐚𝐟𝐭 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 “𝐆𝐞𝐧𝐞𝐫𝐚𝐥 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐔𝐬𝐞 𝐨𝐟 𝐍𝐀𝐌𝐬 𝐢𝐧 𝐃𝐫𝐮𝐠 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭” 𝐦𝐚𝐫𝐤𝐬 𝐚𝐧 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐬𝐭𝐞𝐩 𝐟𝐨𝐫𝐰𝐚𝐫𝐝 𝐟𝐨𝐫 𝐡𝐮𝐦𝐚𝐧-𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 𝐬𝐜𝐢𝐞𝐧𝐜𝐞. Kudos to my colleague Donic for a great summary. If you're interested in the full guidance, you can read it here: https://lnkd.in/gkm7X7C9 At Anivance AI, we are actively contributing to this shift. Our focus is on enabling NAMs to meet these four validation pillars by building predictive models that are verifiable, scalable, and trusted in regulatory contexts, accelerating their adoption in real-world drug development. This guidance sends a clear signal: the future of drug development is human-centric—and increasingly non-animal. #FDA #NAMs #DrugDevelopment #RegulatoryScience #Biotech #AnivanceAI