The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
- New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability
- Strategies To Tackle CAR-T Product Challenges
- Chugai's Race To Zero Emissions At UK4 In Tokyo
- Have We Got Novel Drug Production And Compliance Timelines All Wrong?
- Digitalized Drug Forecasting Minimizes Waste In Clinical Trial Supply Chain
- New Guide Tackles Best Practices For Making Allogeneic Cell Therapies
- FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
- Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products
ON-DEMAND WEBINARS
Learn about supply strategy optimization while balancing the importance of remaining site-centric in this webinar.
Individual data points over time can provide precise drug dosing histories that enable better understanding of protocol adherence, safety, efficacy, PK/PD and a drug’s exposure-response relationship.
In this interactive discussion, IQVIA Technologies' Vice President and General Manager of IRT Kevin Landells and Senior Director of Product Management of IRT Stefan Dürr delve into real-world examples and practical AI applications.
This panel webinar discusses the importance of clinical supply agility and how to mitigate supply chain risk that comes along with clinical supply decisions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cryogenics]( "Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures")
Validating The Stability And Durability Of Labels After Thawing From Cryogenic TemperaturesOne important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.
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![Internet-Medical-Things-iStock-914789708]( "How Are You Labeling Your IP? Protect Your Clinical Trial With Distinct Treatment Numbers")
How Are You Labeling Your IP? Protect Your Clinical Trial With Distinct Treatment NumbersExplore why engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage")
Overcoming The Challenge Of Maintaining Sterility At Low Temperature StorageLearn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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![GettyImages-1359760465 doctor ipad]( "Unified Platform Supports Rapid Implementation Of Rescue Study")
Unified Platform Supports Rapid Implementation Of Rescue StudyExplore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Top Clinical Research Themes And Trends")
Top Clinical Research Themes And TrendsWe analyzed web traffic, content downloads, social media engagement, webinar attendance, and other metrics to determine the themes that caught your attention and aligned with broader industry trends.
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![cryogenic tank 450x300]( "FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies")
FDA Requirements For Packaging Cryogenically Frozen Advanced TherapiesFDA requires packaging and distribution systems to protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
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![GettyImages-1316775813-vial-production]( "Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C")
Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°CThis study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
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![iStock-1288879010-gloves-mask-box]( "5 Common Clinical Supply Chain Speedbumps")
5 Common Clinical Supply Chain SpeedbumpsClinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.
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![GettyImages-1221576332 cell therapy]( "Logistics In Cell Therapy: Reducing Workflow Risk")
Logistics In Cell Therapy: Reducing Workflow RiskExplore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
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![Refrigerated Container cold chain]( "Transportation Solutions For Cell And Gene Therapy Supply Chains")
Transportation Solutions For Cell And Gene Therapy Supply ChainsDeveloping a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.
