Regulatory Affairs Editorial

  1. How To Meet FDA Expectations For Hybrid And Decentralized Trial Oversight 1/5/2026

    Former FDA attorney Claire Davies shares strategies for meeting regulators' expectations for hybrid and decentralized clinical trial oversight.

  2. No Surprise Here: Experts Value Clinical Relevance Over Statistical Relevance 12/31/2025

    Experts weighed in: “Agree or disagree? Statistical significance is preferable to clinical relevance.”

  3. Mock Inspection Advice From Former Regulatory Investigator 12/30/2025

    Former FDA investigator Alia Legaux, D.H.Sc., runs through her top tips for running a mock investigation.

  4. FDA Further Expands And Clarifies Expanded Access FAQs 12/29/2025

    Healthcare attorney Dianne J. Bourque breaks down the FDA's October 2025 update to its Expanded Access FAQs.

  5. Most Ex-U.S. Countries Can't Access The Medicines They Help Study 12/19/2025

    When a country hosts a clinical trial, we assume patients there will eventually benefit from the therapy they helped test. Research Jennifer E. Miller, Ph.D., says that's not often the case.

  6. Poland: An Underestimated Clinical Trials Powerhouse 12/15/2025

    Poland is not “one of the good options” or “an interesting emerging market," says Tomasz Szelag, head of clinical operations, Ryvu Therapeutics. Rather, it should be one of the first places sponsors look to run their clinical trials.

  7. 2026 Forecasts From People Smarter Than Me – Part 1 12/12/2025

    In Part 1 of this forecast series, leaders from TransCelerate, Genentech, Clinical Performance Partners, Marketcap Consulting, and others weigh in on what’s coming next — from regulatory pressure and RBQM mandates to BYOT momentum, AI reality checks, and the financial rebound many CROs are betting on.

  8. Can't-Miss Advice On Selecting Your First AI-Enabled Vendor 12/12/2025

    Quarles & Brady's Simone Colgan Dunlap and Meghan O’Connor offer actionable guidance to help sponsor companies make informed, strategic choices in an evolving AI market.

  9. The 2020 Pediatric Mandate That Shook Up Oncology Research 12/11/2025

    Until 2020, the majority of drugs used in pediatric medicine had not been studied adequately in children. Regulatory expert Bhargavi Pandit recounts the impact the U.S. RACE for Children Act had on pediatric and adult investigational drug trials.

  10. An FDA First: Dompé Shares Experience Of Securing A Commissioner's National Priority Voucher 11/25/2025

    Dompé Chief Development Officer Ahmed Enayetallah reveals how the team earned the FDA's new Commissioner’s National Priority Voucher.