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Regulatory News

16 04, 2026

FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS

2026-06-24T13:50:08+00:00

The FDA’s new draft guidance on genome editing safety marks a significant step toward more standardized, data-driven evaluation of gene therapies.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.

FDA Issues Draft Guidance on Genome Editing Safety Assessment Using NGS2026-06-24T13:50:08+00:00
13 01, 2026

FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation

2026-04-22T18:03:44+00:00

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.

FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation2026-04-22T18:03:44+00:00
16 12, 2025

New FDA Final Guidance on Development of Therapeutic Protein Biosimilars: Analytical Considerations for Biologics Developers

2026-04-22T18:03:47+00:00

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.

New FDA Final Guidance on Development of Therapeutic Protein Biosimilars: Analytical Considerations for Biologics Developers2026-04-22T18:03:47+00:00
24 11, 2025

FDA’s New Plausible Mechanism Pathway: How It Compares to Existing Approval Routes

2026-04-22T18:04:42+00:00

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.

FDA’s New Plausible Mechanism Pathway: How It Compares to Existing Approval Routes2026-04-22T18:04:42+00:00
21 10, 2025

FDA Issues Three New Draft Guidances to Streamline Cell and Gene Therapy Development

2026-04-22T18:03:30+00:00

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...

FDA Issues Three New Draft Guidances to Streamline Cell and Gene Therapy Development2026-04-22T18:03:30+00:00
5 08, 2025

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release

2026-04-22T18:04:14+00:00

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.

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release2026-04-22T18:04:14+00:00
13 05, 2025

FDA Accelerates AI Integration to Transform Drug Review Processes

2026-04-22T18:04:34+00:00

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...

FDA Accelerates AI Integration to Transform Drug Review Processes2026-04-22T18:04:34+00:00
15 04, 2025

US Food and Drug Administration FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

2026-04-22T18:03:29+00:00

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...

US Food and Drug Administration FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs2026-04-22T18:03:29+00:00
18 03, 2025

Empowering Drug Development with CLIA Testing Services

2026-04-22T18:04:11+00:00

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...

Empowering Drug Development with CLIA Testing Services2026-04-22T18:04:11+00:00

ABOUT US

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.

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