CLINICAL SUPPLY REGULATORY ARTICLES
FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay
On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.
CLINICAL SUPPLY REGULATORY VIDEOS
Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.
Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
CLINICAL SUPPLY REGULATORY RESOURCES
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![Machine Converyor With Glass Vials GettyImages-498492002]( "Building Robust Clinical Supply Chains To Support Global Trials")
Ensuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.
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![GettyImages-2162599103-tablet-pen-graphs-data]( "Analytics–Powered Approach To Patient Recruitment Strategy")
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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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-1163506017 labeling]( "IMP Labeling: EU CTR Transition Considerations")
Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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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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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Developing Injectable Drug Placebo Formulations For Clinical Trials")
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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![iStock-1088247762-risk]( "Avoiding The Risk Of A Non-Transparent Clinical Supply Solution")
With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.
