INSIGHTS ON CELL & GENE REGULATORY ISSUES
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![Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.]( "Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.")
Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes.
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![GettyImages-1132960495 EU European Union flag]( "Understanding The EU Regulatory Landscape For Cell And Gene Therapies")
Understanding The EU Regulatory Landscape For Cell And Gene TherapiesEU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.
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![clinical-trials-cros-GettyImages-1346675527]( "How Australia's Leading CRO Is Driving Biotech's Acceleration From First-In-Human To Global Markets")
How Australia's Leading CRO Is Driving Biotech's Acceleration From First-In-Human To Global MarketsThe next era of clinical trials will be defined by global expansion across the Asia-Pacific region, rapid and cost-effective pathways to regulatory approval, and reliable, patient-centric leadership.
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![From Fermentation To Vaccination]( "From Fermentation To Vaccination")
From Fermentation To VaccinationNon-animal-origin squalene is gaining momentum in vaccine adjuvants. See how fermentation-derived squalene delivers comparable performance, strong stability, and regulatory alignment.
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![Medical team, tablet, meeting-GettyImages-2177971058]( "Real-World Evidence Revisited")
Real-World Evidence RevisitedExplore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.
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![GettyImages-2200850893-US-FDA-Food-Drug-Administration]( "General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update Means")
General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update MeansThe FDA’s 2026 guidance has put an end to "wellness by disclaimer." Learn how new standards for wearables and apps impact study design, participant safety, and the evolving ethical role of the IRB.
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![coding, application development, software-GettyImages-2012746930]( "Clinical Decision Support Software: Clear Expectations For Research Oversight")
Clinical Decision Support Software: Clear Expectations For Research OversightThe FDA’s 2026 CDS guidance signals a shift to settled policy. IRBs must now demand greater transparency regarding automation bias and clinician independence to accurately assess study risk.
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![GettyImages-1551861554-FDA]( "The FDA's Final BIMO \"Processes And Practices\" Guidance")
The FDA's Final BIMO "Processes And Practices" GuidanceGain a clear roadmap for investigators, sponsors, and IRBs. This shift toward transparency replaces regulatory guesswork with predictable standards for every partner in the research ecosystem.
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![GettyImages-1245953899 IRB compliance]( "What Does The FDA's 2025 Safety Reporting Guidance Mean For You?")
What Does The FDA's 2025 Safety Reporting Guidance Mean For You?New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.
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![Prioritizing Quality, Fit, and Supplier Reliability in CGT Materials]( "Prioritizing Quality, Fit, And Supplier Reliability In CGT Materials")
Prioritizing Quality, Fit, And Supplier Reliability In CGT MaterialsIn this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss why companies should prioritize technical fit, quality, and supply chain reliability when selecting materials in cell and gene therapy.
