Regulatory News
Navigating the evolving landscape of drug development and regulatory compliance can be complex and challenging. From FDA guidance updates to international regulatory changes, staying informed is critical for researchers, biotech innovators, and pharmaceutical professionals. This page brings you a curated list of the most important news in drug development regulation, highlighting updates from the FDA, EMA, and other regulatory bodies around the world
The FDA released three new draft guidances to streamline cell and gene therapy development. The documents outline innovative trial designs for small populations, expedited pathways for serious conditions, and improved postapproval methods for monitoring long-term safety and efficacy...
When a gene therapy company needed to verify plasmid identity, purity, and integrity for an IND submission, Avance Biosciences delivered a validated NGS-based solution. The assay enabled low-level variant detection and trace contaminant analysis, supporting FDA compliance and lot release.
Avance delivers end-to-end NGS workflow compliance with a robust framework for data integrity, pipeline validation, and audit readiness—tailored for regulated environments...
The FDA is embracing AI to streamline drug reviews, aiming for full implementation by June 2025. Following a successful pilot, this move could fast-track therapy approvals and reduce administrative tasks for scientists...
The FDA is phasing out animal testing for monoclonal antibodies and other drugs, turning to AI, lab-grown human tissues, and global safety data to streamline development, cut costs, and improve patient safety...
Avance Biosciences offers CLIA-compliant testing services to ensure accurate, reliable data throughout drug development. From biomarker validation to regulatory support, our expertise helps biopharmaceutical companies advance clinical trials and bring innovative biologic treatments to market with confidence...
HOUSTON, Feb. 26, 2025 /PRNewswire/ -- Avance Biosciences, a leading provider of high-quality analytical and bioanalytical services for the pharmaceutical industry, is pleased to announce that it has successfully registered with [...]
Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma...
Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period, according to a recent study...
The guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety...