CLINICAL SUPPLY REGULATORY ARTICLES
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.
CLINICAL SUPPLY REGULATORY VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.
Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.
CLINICAL SUPPLY REGULATORY RESOURCES
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![audit management]( "Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio")
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
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![iStock-1224887299-box-logistics-package]( "The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective")
Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
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![iStock-1288879010-gloves-mask-box]( "5 Common Clinical Supply Chain Speedbumps")
Clinical 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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![Medical-research-GettyImages-1266341847]( "The Changing Landscape Of Oncology Drug Development")
Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.
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![GettyImages-1288438537 ecosystem]( "Clinical Research As A Delicate Ecosystem")
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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![GettyImages-1214112149-lab-team-collaboration-research]( "Creating Accurate, Efficient, And Effective CDMO Project Proposals")
To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.
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![Scientist research laboratory pipette GettyImages-487041629]( "Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions")
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
