Regulatory Articles

  1. Botanical QT Risk Starts In The Extract 11/6/2026

    For a plant-derived drug candidate, the proarrhythmic liability belongs to the preparation rather than to the molecule named on the label.

  2. Botanicals: Ask For Reuse, Not Relief 11/3/2026

    The FDA has a botanical drug docket open until Nov. 3, 2026, which requests information on blocks to botanical drug development, study designs, and how real-world evidence might help development.

  3. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

    FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

  4. When The Cat Is Away: The Institutional Test Of FDA Modernization 10/27/2026

    Congress has an opportunity in 2027 to restore the FDA Modernization Act 3.0's broader ambitions and establish a more accountable framework for biomedical modernization. 

  5. Discovery & Development US 2026 - Key Notes From San Diego 10/19/2026

    Key takeaways from D&D US 2026 on Pfizer’s complex oncology targets, AI-enabled discovery, and the shift toward human-based NAMs.

  6. Bravo, FDA For Retiring 'Animal Testing' In Favor Of 'Nonclinical' 9/28/2026

    HHS is advancing human-based drug research through new FDA terminology, NIH infrastructure, CDC studies, and ARPA-H tools that reduce reliance on animal testing.

  7. The Continuing Challenge Of Drug-Induced Liver Injury 9/24/2026

    Recent liver safety concerns highlight the limits of conventional preclinical testing. Human-relevant models could help researchers detect drug-induced liver injury earlier and reduce costly setbacks.

  8. Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs? 9/15/2026

    Part 2 follows the consequences into Wall Street, asking what better evidence could mean for pharmaceutical valuations and, ultimately, drugs already in the portfolio.

  9. Wall Street Is Wary Of NAMs — And For Good Reason: The Evidentiary Shift 9/10/2026

    Part I of this series focuses on the evidentiary shift of how NAMs may change the architecture of evidence and how that transition unfolds.

  10. What The China Biotech Debate Reveals About U.S. Drug Discovery 8/17/2026

    Peter Kolchinsky and Jason Kelly sparred over China’s biotech rise and what it means for U.S. drug discovery, investment, and strategic control.