More insights from the FDA on implementing new approach methodologies were just published in JAMA. https://jamanetwork.com/journals/jama/fullarticle/2848148?resultClick=1 ...
Thank you, Allison, Yes, everyone is invited to join Regulatory Science and other, or all communities, so we can be better connected across disciplines. ...
Draft guideline was issued and comments must be submitted to FDA by 6/22/2026. Let us know if anyone is interested to provide comments. Establishing ...
Over the past few months, FDA has released several guidance's and discussion documents that collectively point to a stronger emphasis on mechanistic understanding, ...
Encouraging to hear that PEPFAR and the Global Fund will support expanding access to lenacapavir for an additional 1 million users, bringing the total ...