Regulatory and Standard Setting Organizations

FDA's new rule formally recognizes non-animal methods like organoids and AI models as valid ways to support human drug testing.

New data show risk-based and centralized monitoring shifts effort across roles, sites, and timelines, reshaping how sponsors plan CRA capacity needs.

FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.

Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.

FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.

Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.

FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.

AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.