Regulatory Affairs Editorial

  1. Your Company Needs Compliance Expertise — But When And From Whom? 10/8/2026

    When should a biotech formalize compliance? Learn how risk, funding, clinical activity, and commercialization shape the right expertise and structure.

  2. Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System 10/2/2026

    Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.

  3. How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy 9/30/2026

    As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.

  4. Long-Distance Rare Disease Trials: Why PLL Landed On Australia And New Zealand 9/29/2026

    Australia and New Zealand had a lot to offer PLL Therapeutics, but speed and savings aren't the only upsides for running its rare disease trial from its European home.

  5. In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies 9/17/2026

    I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.

  6. Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy 9/17/2026

    When three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.

  7. Clinical Supply Systems Need IT General Controls 9/14/2026

    Validating a clinical trial system does not prove it stays trustworthy. IT general controls can protect data, supply decisions and patient safety long after go-live.

  8. Why ING Feels Different 9/11/2026

    I’ve attended enough clinical trial conferences to know how similar they can feel. ING is different. Its Dive Teams, WhaleTank, and candid conversations are designed to get attendees participating, not just listening. This year, I’m especially interested in an off-the-record regulatory panel that could tackle some of the biggest changes facing clinical research.

  9. Clinical Trial Standards — What They Are And Why They're Indispensable 9/8/2026

    Clinical trial standards are essential. But to interpret changes, preserve meaning, and assess downstream impact, context is key.

  10. The Reality Of Clinical Research Federal Funding Cuts 8/20/2026

    Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.