Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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?"

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 FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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

  5. 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.

  6. 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. 

  7. How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial 2/11/2025

    PDS Biotech CMO Kirk Shepard reveals his team’s interactions with the FDA as it sought to begin its Phase 3 trial for the treatment of HPV-positive recurrent and/or metastatic head and neck squamous cell carcinoma.

  8. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  9. Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars 2/10/2025

    With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.

  10. Input Needed On Using AI To Create Lay Summaries Of Trial Results 2/7/2025

    CISCRP is soliciting feedback from research professionals, patients, and advocacy groups on its "Considerations for Using AI to Create Lay Summaries of Trial Results" until Feb. 18.