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

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, lays out the phases and key activities in the development of a combination product or combination therapy. She underscores the importance of integrated development when merging medicinal product development with delivery device development. 

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 asks panelist Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.

In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, uses the example of a connected pen cap to discuss technology, patient, and market considerations at the intersection of drugs, devices, and data.

In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

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  • 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).

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