Regulatory Articles

  1. 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.

  2. 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.

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 FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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

  4. 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.

  5. 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.

  6. 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.

  7. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

  8. FDA's CBER Issues Final Guidance For CAR T Cell Products 2/15/2024

    The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.

  9. FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products” 1/26/2024

    Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”

  10. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.