Biosafety
Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
Reporting Unexpected Incidents to the IBC
Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.
Improving Study Activation Time for Gene Therapy Research
With the growing popularity of gene therapy research and genetically engineered vaccines, sites need to understand study activation impacts
IBC vs. IRB: What’s the Difference?
Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).
Navigating Key Complexities in the Development of Cell and Gene Therapies
Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.
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.
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