Biosafety
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Advarra Achieves 1,000+ Site Milestone for its Gene Therapy Ready Network
Research involving gene therapy-based treatments can start more quickly with Advarra’s growing network of registered research sites.
FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products
Our IBC experts authored “FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products” in Applied Biosafety.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
Safe Sharps Handling When Dispensing Investigational Products
Care must be taken to avoid sharps-related injuries and exposures when preparing investigational products for clinic transportation.
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Using hoods with biological materials depends on directional airflow, and specialized airflow is necessary when handling hazardous materials.
Four Questions to Ask When Establishing a Pharmacovigilance Organization
Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.
Clinical Trial Superheroes
Download this eBook to learn about the individuals who dedicate their talents to give patients an opportunity for healthier and longer lives.
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