INHALATION DRUG DELIVERY ARTICLES

25_DDL_Regulatory_Reconnaissance_logo_color Human Factors: A Key Factor In Regulatory Approvals

In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.

INHALATION DRUG DELIVERY VIDEOS

In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies. 

In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for an on-body injector (OBI) to demonstrate a template for identifying EDDOs.

In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, highlights the promise of using combination products and combination therapies to reach difficult targets with precision. Carolyn notes crossing the blood-brain barrier as an example of a key therapy delivery advance. 

In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.

  • 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.

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

  • 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.

  • 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.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

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

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

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

  • 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.