Cell and Gene Regulatory

  1. FDA Leading The Decline Of Animal Testing 7/16/2025

    The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

  2. Redefining CGT With Exosomes And EVs 7/16/2025

    July’s Cell & Gene Live featured a comprehensive look at the scientific advances, clinical promise, manufacturing hurdles, and regulatory considerations shaping extracellular vesicle and exosome-based therapies. 

  3. Accelerating Gene Therapy Development For NEDAMSS 7/15/2025

    Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

  4. Trusted Partner For Clinical And Regulatory Success 7/15/2025

    Novotech’s Regulatory Affairs team offers customized, end-to-end clinical and regulatory solutions, guiding biotechnology, pharmaceutical, and medical device companies through the entire product lifecycle.

  5. Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress 7/15/2025

    Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

  6. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

    Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

  7. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

  8. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

    The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

  9. Redefining CGT With Exosomes And EVs 7/10/2025

    Cell & Gene Chief Editor Erin Harris shared a timely discussion on the latest advancements and opportunities in the rapidly evolving field of exosomes and extracellular vesicles (EVs) within cell and gene therapy.

  10. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.