Regulatory Affairs Editorial

  1. Solving The Protocol Deviation Puzzle With FDA Draft Guidance 3/14/2025

    Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.

  2. Takeda's Diversity Strategy Pays Off For Phase 3 Trial 3/12/2025

    LaShell Robinson, head of global feasibility and trial equity at Takeda explains how the company’s Phase 3 trial for a psoriasis drug ended enrollment well before it’s goal and achieved some impressive diversity metrics. 

  3. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

  4. Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3 3/6/2025

    In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.

  5. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

  6. Breaking Down The FDA's Latest Guidance On Electronic Systems In Clinical Investigations 2/28/2025

    In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

  7. U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance 2/28/2025

    Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"

  8. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

  9. Day One Bio's Talks With FDA Help Secure Glioma Drug Approval 2/14/2025

    Day One CMO Elly Barry, MD recounts the company's experience working with the FDA and turning a passed-over drug into its first-ever approved treatment for pediatric glioma patients.

  10. Roche Diagnostics Guides New Alzheimer's Test Through Trials 2/12/2025

    Roche Diagnostics’ Maria-Magdelena Patru, MD, PhD discusses their plasma test and how they’re approaching its clinical trials.