ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a new ACT video interview, Charlie Paterson, partner at PA Consulting, says reduced FDA capacity and staff turnover in 2025 have directly lengthened regulatory planning and review timelines. He explains that uncertainty around feedback has pushed sponsors to invest more upfront effort in submissions and meeting preparation, while slower responses and delayed interactions are extending development timelines. Paterson notes that the loss of institutional knowledge has made early guidance on innovative study designs harder to access.
• In a new FAQ-style article, industry experts say sponsors are rethinking operating models to scale trials globally without overwhelming sites. Insights from Kevin Williams of Ledger Run highlight growing concern over site “switching burden” caused by inconsistent systems, processes, and CRO models. Sponsors are increasingly exploring functional sourcing, standardization, and tighter alignment of technology and partnerships to reduce friction for sites as trials expand into emerging markets and decentralized models grow.
• The FDA and EMA have jointly released ten guiding principles for good AI practice across the medicines lifecycle, signaling closer regulatory alignment on artificial intelligence use in drug development. The principles outline a human-centric, risk-based approach to AI across research, clinical trials, manufacturing, and post-market surveillance, emphasizing data governance, transparency, and lifecycle monitoring. Regulators say the framework will underpin future guidance as AI adoption accelerates across regulatory submissions.

That’s all for today’s ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.