INHALATION DRUG DELIVERY ARTICLES

25_DDL_Regulatory_Reconnaissance_logo_color 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

Can a diligent focus on patient safety during combination product development inadvertently lead to missed opportunities for device use enhancements? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, discusses ways to keep the organization focused on developing quality products that enhance user adoptability while also mitigating user-related harm.

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, panelists Carolyn Dorgan and Courtney Evans from delivery device consultancy Suttons Creek talk with host Fran DeGrazio about factors creating challenges and opportunities in moving patients to on-body injectors (OBIs) and other wearable drug delivery systems.

How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, describes the differences between the two concepts, including how they differently relate to considerations of risk.

In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, Chief Editor Tom von Gunden asks panelist Geraldine Venthoye about innovations in inhalation formulation and delivery for enabling expanded and precision therapeutic targeting. Venthoye points to key aspects of particle science and payload release, as well as the need for advanced analytical tools. 

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • 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.

  • Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  • 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.

  • 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.

  • 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.

  • See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.

  • Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.

  • Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.