Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development 8/13/2026

    Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.

  6. What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors 8/13/2026

    Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.

  7. How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy 8/12/2026

    Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.

  8. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  9. Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic 7/30/2026

    As FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.

  10. From The Lab To Regulations As An IRB Specialist 7/17/2026

    In this 8-question Q&A, Ribu Goyal, an IRB specialist and scientific reviewer at the Mayo Clinic Office for Human Research Protection, talks about everything from the details of her job to how sponsors could improve their collaboration with their IRBs.