INHALATION DRUG DELIVERY ARTICLES
Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes.
INHALATION DRUG DELIVERY VIDEOS
What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.
Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.
What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.
INHALATION DRUG DELIVERY RESOURCES
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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![GettyImages-1213498599-lab-research-microscope]( "Complex Molecules, Complex Problems")
The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
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![Delivered _by _DeGrazio_Logo_Color_2]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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![iStock-146792998-capsule-powder-pill]( "Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development")
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
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![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
INHALATION DRUG DELIVERY SOLUTIONS
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![lung-health-GettyImages-1360866086]( "Fast-Tracking Healthier Tomorrows For Patients And Our Planet")
A focused look at how low‑GWP propellant technologies support sustainability goals while preserving inhaler performance, offering guidance for planning regulatory readiness, device compatibility, and long‑term respiratory portfolio strategy.
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![Biological drug products]( "Blow/Fill/Seal Packaging Systems")
Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.
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![inhaler-GettyImages-2233485493]( "Pulmonary Drug Delivery")
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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![Nasal spray, allerfies, common cold-GettyImages-2147519597]( "Nasal Drug Delivery")
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![pulmonary-GettyImages-2148494976]( "Pulmonary")
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
