Regulatory Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

    As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

  6. Is Your Intellectual Property Safe With Indian CROs And CDMOs? 6/3/2024

    Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.

  7. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

  8. Emulate Endorses The FDA Modernization Act Of 2021 5/10/2024

    Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.

  9. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

  10. FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

    On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.