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.

The FDA has approved a label update for Merck's Winrevair (sotatercept-csrk) incorporating Phase 3 HYPERION data, showing a 76% reduction in clinical worsening events when added to background therapy in adults diagnosed with pulmonary arterial hypertension within the past year.