Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. 

  7. 5 Informed Consent Fixes For Sponsors And Investigators 7/14/2026

    Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

  8. Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development 7/13/2026

    UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .

  9. Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1) 7/10/2026

    The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.

  10. Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2) 7/10/2026

    The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.