Keeping up with new FDA guidance documents can be challenging. The FDA regularly publishes new draft and final guidance covering topics ranging from drug development and manufacturing to diagnostics, biologics, cell and gene therapy, medical devices, and regulatory policy...
The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies. With next-generation sequencing (NGS) at the core, the guidance outlines clear expectations for assessing off-target effects, genomic integrity, and rare editing events, providing sponsors with a more defined regulatory path for IND and BLA submissions.
The FDA is clarifying its flexible approach to chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies, helping sponsors accelerate development and prepare for Biologics License Applications while maintaining rigorous standards for safety, quality, purity, and potency.
The FDA’s new guidance on therapeutic protein biosimilars emphasizes rigorous analytical assessment as the foundation for demonstrating similarity. Developers must focus on physicochemical, functional, and quality attributes to streamline regulatory approval and reduce clinical study requirements.
Explore the FDA’s new Plausible Mechanism Pathway and how it compares to accelerated approval, expedited programs, and other regulatory routes for rare disease therapies.
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 is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
