Regulatory Articles

  1. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

  2. 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.

  3. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

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 FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  6. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

  7. How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS 12/6/2024

    The company’s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.

  8. Keys To Successful CMC Source Document Preparation For Cell & Gene Therapies 10/1/2024

    Chemistry, manufacturing, and controls (CMC) source documents are the foundation for module 3 of a cell/gene therapy FDA regulatory submission.

  9. AI Is A Tool — Not A Replacement — For Human Innovation In Drug Discovery 9/4/2024

    This attorney provides practical advice. Can artificial intelligence (AI) make drug discovery easier? Yes! Will we lose the human component essential to the innovation culture? No.

  10. Cell Therapies For Solid Tumors: Optimizing Your Approach To Achieve Regulatory Approval 6/19/2024

    Developing and ultimately obtaining approval of cell therapies for solid tumors requires an organized and scientifically rigorous approach. This article is a helpful road map of considerations.