SOLUTIONS

• Engage Early With The FDA On AI … Or Expect Problems

  You've heard it before; sponsors must engage FDA early when using AI in clinical development. Hilary Marston warns that late engagement can cause irreparable damage to your regulatory strategy.

• CRL Transparency Comes With Real Trade-Secret Risks

  Sure, increased transparency around Complete Response Letters sounds good, but Elizabeth Jungman warns that FDA’s new disclosure approach may expose sponsors’ confidential and commercially sensitive information.

• Can The FDA Easily Replace The Experience It Has Lost?

  Elizabeth Jungman describes how early retirement programs and workforce reductions led to the loss of highly experienced FDA leaders, creating gaps in institutional knowledge that affect complex regulatory decisions.

• We Can't Really Interpret R3 In A Vacuum

  Having problems interpreting ICH guidelines or deciding what to do next? Sophia McLeod offers some advice and resources, and then she also explains why she thinks it’s good that we’re living in this “show-your-work” kind of era.

• FDA Talent Loss Is Real — And It's Not Evenly Distributed

  Hilary Marston discusses how staffing losses at FDA are uneven across divisions, with particularly heavy impact in innovative areas like AI and real-world evidence.

• Policy by Press Release Is Now a Real Problem

  Sophia McLeod, advocacy advisor, at ACRO, explains what ACRO members are concerned about regarding the FDA staffing losses. She also talks about the effects of "policy by press release" rather than traditional notice-and-comment periods.