Industry Insights

  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. 5 Signs Your Clinical Trial Needs Outside Help 8/13/2026

    Could you use some outside help? The right outside partner can bring the expertise, capacity, and perspective needed to get studies back on track.

  4. The Regulatory Compass Driving Drug Delivery Innovation 8/12/2026

    Regulatory requirements are growing more complex. Discover how strategic planning, regulatory intelligence, and platform approaches can streamline development and approvals.

  5. Insights From DPHARM: Reimagining The Future Of Connected Clinical Trials 8/12/2026

    Connected technologies are enabling smarter clinical trials. Discover how remote data capture and decentralized approaches can reduce burden and improve patient engagement.

  6. MIDBA: A New Regulatory Approach To Clinical Device Bridging 8/12/2026

    When devices evolve, evidence expectations can shift. Explore a risk-based clinical bridging approach to support regulatory decisions.

  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. Why Vendor Oversight Breaks Down At Handoffs 8/11/2026

    Is a vendor handoff really complete once the file is sent? Not quite. Sponsors still need context, ownership, and evidence to keep trials moving.

  9. Don't Accept This Site-Level Start-Up Bottleneck— Instead, Learn How To Stop It 8/10/2026

    Combining investigator meetings and SIVs can cut site activation timelines in half — if sponsors build a compliance-sound case and involve QA early.

  10. 7 Practical Implications Of ICH E6(R3) For Early-Phase Trial Design 8/10/2026

    A risk-based quality approach can enhance participant protection, data integrity, and development success through focused oversight, strong governance, and clear documentation.