REGULATORY ARTICLES
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![Turning gears on human heart-GettyImages-1313678724]( "Botanical QT Risk Starts In The Extract")
Botanical QT Risk Starts In The ExtractFor a plant-derived drug candidate, the proarrhythmic liability belongs to the preparation rather than to the molecule named on the label.
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![RFI, request for information-GettyImages-1159025084]( "Botanicals: Ask For Reuse, Not Relief")
Botanicals: Ask For Reuse, Not ReliefThe FDA has a botanical drug docket open until Nov. 3, 2026, which requests information on blocks to botanical drug development, study designs, and how real-world evidence might help development.
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![FDA-GettyImages-2271237562]( "An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?")
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
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![FDA - Food and Drug Administration, red Speech bubble-GettyImages-2213848387]( "When The Cat Is Away: The Institutional Test Of FDA Modernization")
When The Cat Is Away: The Institutional Test Of FDA ModernizationCongress has an opportunity in 2027 to restore the FDA Modernization Act 3.0's broader ambitions and establish a more accountable framework for biomedical modernization.
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![GettyImages-2158228359]( "Discovery & Development US 2026 - Key Notes From San Diego")
Discovery & Development US 2026 - Key Notes From San DiegoKey takeaways from D&D US 2026 on Pfizer’s complex oncology targets, AI-enabled discovery, and the shift toward human-based NAMs.
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![GettyImages-1251894563]( "Bravo, FDA For Retiring 'Animal Testing' In Favor Of 'Nonclinical'")
Bravo, FDA For Retiring 'Animal Testing' In Favor Of 'Nonclinical'HHS is advancing human-based drug research through new FDA terminology, NIH infrastructure, CDC studies, and ARPA-H tools that reduce reliance on animal testing.
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![GettyImages-2280454860-scientist-liver-organ-research]( "The Continuing Challenge Of Drug-Induced Liver Injury")
The Continuing Challenge Of Drug-Induced Liver InjuryRecent liver safety concerns highlight the limits of conventional preclinical testing. Human-relevant models could help researchers detect drug-induced liver injury earlier and reduce costly setbacks.
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![Investment in medical and pharma business GettyImages-1299804755]( "Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs?")
Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs?Part 2 follows the consequences into Wall Street, asking what better evidence could mean for pharmaceutical valuations and, ultimately, drugs already in the portfolio.
REGULATORY VIDEOS
Episode 141 of Cell & Gene: The Podcast features Host Erin Harris' discussion with Ali Pashazadeh, Founder, Chairman, and CEO of Treehill Partners, about the manufacturing challenges that continue to limit cell and gene therapy development.
In Episode 140 of Cell & Gene: The Podcast, Erin Harris speaks with Dr. Remo Moomiaie-Qajar of Axiom Biosciences about the company’s delivery-focused approach to developing regenerative and genetic medicines.
Explore how human-relevant liver models can improve DILI risk assessment and support stronger development decisions while advancing toward regulatory qualification and scaling into automated studies.
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer.
REGULATORY ARTICLES. APP NOTES, CASE STUDIES. & WHITE PAPERS
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![GettyImages-1389546565-lab-bioreactor]( "Beyond The Bioreactor Scaling CGT Ancillary Materials With The EntoEngine™")
Growing demand for cell and gene therapies is increasing pressure on cytokine production. Explore interleukin manufacturing, quality, consistency, safety, scalability, and supply reliability.
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![GettyImages-2280454860-scientist-liver-organ-research]( "The Continuing Challenge Of Drug-Induced Liver Injury")
Recent liver safety concerns highlight the limits of conventional preclinical testing. Human-relevant models could help researchers detect drug-induced liver injury earlier and reduce costly setbacks.
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![GettyImages-1002000796-lab-research-scientist-development]( "A Timeline Of U.S. Actions To Reduce Animal Models In Research")
Policy and scientific validation have aligned to shift drug development beyond animal models. New regulations and technologies are making human‑relevant methods the standard for preclinical research.
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![enzymes-drug-conjugte-GettyImages-1343098807]( "How AstraZeneca Is Managing Their Extractables And Leachables Data")
Hidden packaging and drug interactions pose real risks. A collaborative knowledge base helps scientists unify data, improve decisions, and advance safer development through accessible E&L insights.
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![GettyImages-2190243697-modern-lab-researching]( "Sustainable Analytical Labs: Software For Greener Chromatography")
Chromatography's environmental footprint is often overlooked. Applying green chemistry principles reduces solvent use and waste, unlocking sustainable workflows without losing performance.
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![GettyImages-2261840472-scientist-computer-in-lab-chemical-equations-on-screen]( "How To Choose NMR Data Analysis Software That's Right For You")
NMR data holds deep insights, but extracting them requires the right tools. Smart software improves accuracy and workflows, turning complex spectra into clear, actionable understanding.
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![ai-data-analytics-GettyImages-2262212786]( "NMR Spectroscopy Data—Beyond Single Structure Verification")
NMR reveals far more than structure, offering insights into purity and molecular behavior. Advanced analysis unlocks deeper value from data to better understand mixtures and 3D structures.
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![scientists chemists laboratory-GettyImages-1055312560]( "Sustainable Catalysis")
Catalyst selection is vital for green chemistry. Balancing efficiency and environmental impact requires smart decisions to advance sustainable synthetic methods without losing performance.
REGULATORY SOLUTIONS
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![QIAsprint]( "Breaking The Limits Of Automated Sample Preparation")
Automated nucleic acid purification can deliver high throughput without limiting flexibility or consuming valuable bench space. See how adaptable workflows support efficient sample preparation.
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![GettyImages-1140492414-bioluminescience-assay-bioluminescent-pipette-glow]( "Preclinical Genome Editing Risk Assessment Services")
Regulatory-aligned off-target risk assessment for genome editing programs, from early guide RNA screening through IND-enabling confirmation studies, structured to support FDA submission requirements.
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![GettyImages-1426756188-scientists-in-lab-with-computer-analyzing]( "Assess the Safety Profile Of Pharmaceutical Impurities")
Predict Genotoxic & Carcinogenic Endpoints to Meet ICH M7(R2) Guidelines
ACD/Impurity Profiling Suite predicts a variety of toxicological endpoints to help you assess the genotoxic and carcinogenic potential of impurities and degradants. Developed through a collaborative agreement with the US Food and Drug Administration (FDA), the software can be used as part of your ICH M7(R2) workflow—to help prepare regulatory submissions and remain compliant.
- Determine the ICH M7(R2) classification for impurities and degradants
- Predict 21 toxicological endpoints from structure; for mechanisms of hazardous activity including:
- Mutagenicity (AMES test and other procaryote and eucaryote test systems)
- Clastogenicity
- Other DNA damage
- Carcinogenicity
- Endocrine disruption mechanisms
- Identify potentially hazardous structural fragments responsible for carcinogenic and genotoxic activity
- Gain insight into the possible mechanisms of toxic effects
- Assess the reliability of predictions
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![GettyImages-2194013442-laboratory-scientists-computer-evaluating]( "Assess The Safety Of Pharmaceutical Impurities In Silico")
Advance impurity risk assessment with predictive modeling that clarifies toxicity mechanisms, strengthens regulatory arguments, and reduces experimental burden—helping teams make confident decisions.
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![sterisart thumb]( "21 CFR Part 11 Compliance Checklist For A Universal Pump")
This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.
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![sterisart 2 thumb]( "Sterility Testing For A Connected Era")
This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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![Egnyte Gxp]( "GxP Compliance Software For Life Sciences (21 CFR Part 11)")
Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.
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Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.
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Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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![GettyImages-1400218353-eco_environment_city_green_sustainable]( "Small Is Powerful, Small Is Green")
As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.
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Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards.
