TRANSDERMAL DRUG DELIVERY ARTICLES
7 Management Strategies For Combination Product Regulatory Success
In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success.
TRANSDERMAL DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.
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, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.
How are EDDOs (Essential Drug Delivery Outputs) related to Design Controls during the design and development of a combination product? 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 illustrates how the concept of Design Outputs fits within the broader context of Design Controls.
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.
TRANSDERMAL DRUG DELIVERY RESOURCES
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![combination]( "Combination Products: Market Trends And Regulatory Considerations")
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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![GettyImages-1346675538-lab-research-development-test tubes]( "Solubility With Lipid-Based Technologies For Oral & Injectable Formulations")
Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
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![GettyImages-1448043410 3D printing]( "3D Screen Printing: Enabling A New Generation Of Complex Formulations")
Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![AI-Enhanced Drug Discovery-GettyImages-2196697516]( "Microphysiological Systems: Closing The Gap Between Models And Medicine")
Microphysiological systems (MPS) use human cells to model tissue function, offering faster, more predictive insights for drug discovery, safety testing, and personalized medicine—bridging gaps left by animal and 2D models.
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![GettyImages-1264101698-lab-research-scientist]( "Formulation Development From Preclinical To First-In-Human")
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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![gettyimages-1253545551-170667a (1)]( "Wet Milling Vs. Dry Milling In The Pharmaceutical Industry")
Read about the considerations necessary for choosing between wet milling and dry milling for a specific active pharmaceutical ingredient.
TRANSDERMAL DRUG DELIVERY SOLUTIONS
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![GettyImages-1354171846-lab-research-development]( "End-To-End Drug Development, Analytical Testing, & Fill/Finish")
August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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![Kindeva1]( "Your Partner For The Science Of Skin")
We know what it takes to deliver drug products to and through the skin. Explore drug-in-adhesive patches, solid microneedles (sMTS), and hollow microneedles (hMTS).
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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.
