In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Hospital To Home: What It Means For Patients, Providers And Medical Devices
Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.
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The Gateway Delivery To The Brain
Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
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Integrated Strategies for Achieving Regulatory Milestones Faster
Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.
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Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System
Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.
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Guidelines For Selecting A Medical Device Contract Manufacturer
Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.
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Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs
Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.
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How To Leverage Modeling And Simulation In The Candidate Development Stage
Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.
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Recent Innovations And Enhancements To Pharmaceutical Spray Drying
Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.
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The Role Of Micronization In The Journey To Drug Product Development
Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.
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Customized Release Through Dispersed Dosage Formats
Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

