Regulatory Affairs Editorial

31. Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic 4/9/2026

    MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection. 

32. The Much-Feared FDA Form 483, Part 3 4/8/2026

    This final installment in this three-part series offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs.

33. Why Clinical And Commercial Development Must Be Integrated Fully And Early For FDA And Reimbursement Success 4/6/2026

    With clear alignment among clinical development, regulatory, and commercial development processes, sponsor companies can better prepare for FDA approval and successful Medicare reimbursement.

34. With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout 4/3/2026

    Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension. 

35. The Much-Feared FDA Form 483, Part 2 3/31/2026

    Dr. Robert Califf argues that FDA Form 483, while useful for identifying issues in clinical research, is often applied punitively, causing reputational harm and unnecessary complexity. He advocates for a contextual, quality‑focused approach supported by AI and modernized guidelines to improve evidence generation efficiently.

36. Building A Future-Proof, GxP-Compliant IT Infrastructure 3/31/2026

    Learn how a structured IT evaluation framework can help companies model total compliance costs, request vendor qualification evidence, and embed governance requirements into infrastructure selection.

37. The Much-Feared FDA Form 483 3/31/2026

    Dr. Robert Califf explains that FDA Form 483 is often misunderstood as a final judgment, when it is actually an initial notice of potential issues found during inspections. He argues the form should be seen as a tool for quality improvement, not a proxy for overall performance, and he calls for more efficient processes to reduce unnecessary anxiety and delays.

38. Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing 3/27/2026

    Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.

39. Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2) 3/26/2026

    In the second part of their series on Elsa AI model migration, Kimberly Chew, Esq., and Michael Yang, Esq., analyze the risks to compliance and data residency, as well as the integrity of the regulatory record.

40. From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs 3/25/2026

    Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.