The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- Surgical Therapeutic Design: Key Considerations In Formulation And Delivery
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- When Software Becomes Part Of The Medicine
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
- Treatment Adherence And Designing Therapeutics To Meet Patient Needs
- Complaints Into Practical Action: Human Factors Drug Delivery
- Human Factors: A Key Factor In Regulatory Approvals
ON-DEMAND WEBINARS
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.
Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial scale equipment of challenging applications or molecules.
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1371993517-syringe-vial-mask-vaccine-inject]( "Advancing Chronic Care Through GLP‑1 Innovation")
Advancing Chronic Care Through GLP‑1 InnovationGLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
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![GettyImages-1203324464-decision-arrow-target-goal]( "Guidelines For Selecting A Medical Device Contract Manufacturer")
Guidelines For Selecting A Medical Device Contract ManufacturerConsider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.
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![GettyImages-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Key Considerations For Emerging Companies When Selecting Packaging ComponentsRecognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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![GettyImages-1346675635-lab-tablet-research-team]( "Partnering With Clinicians To Improve Pediatric Formulation Development")
Partnering With Clinicians To Improve Pediatric Formulation DevelopmentGreater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
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![Self injection med device GettyImages-1322057207]( "Overcoming Wet Injection Challenges With Human-Centric Design")
Overcoming Wet Injection Challenges With Human-Centric DesignBy understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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![Wooden blocks PFAS-GettyImages-2145498657]( "Q&A: Navigating PFAS In Medical Devices")
Q&A: Navigating PFAS In Medical DevicesExplore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
Sample Sizes For Performance Testing Of Combination Products, PackagingWhen developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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![GettyImages-1306440102-sterile-injectable-syringe]( "The Growth Of Sterile Injectables")
The Growth Of Sterile InjectablesLearn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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![GettyImages-1346739457-environmental-sustainability-pill-tablet-capsule-OSD-green]( "Reducing Environmental Impact At All Stages Of The Medicine Journey")
Reducing Environmental Impact At All Stages Of The Medicine JourneyExplore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.
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![West]( "Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform")
Selecting A Vial Container Closure System With The DeltaCube™ Modeling PlatformUnderstand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
