TRANSDERMAL DRUG DELIVERY ARTICLES
How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?
FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.
TRANSDERMAL DRUG DELIVERY VIDEOS
After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device. In this segment of the Drug Deliver Leader Live! event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC provides the rationale for a risk-based approach to EDDO control strategies.
In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.
From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind. Cross-functional coordination, integrated development, and primary mode of action (PMOA) designations are among the considerations Barr reminds organizations to implement thoughtfully as they work to advance combination products within a regulatory landscape.
Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.
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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![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-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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![GettyImages-533059254-mRNA_DNA_gene_therapy]( "Combining Gene Therapies, Carrier Systems, And Medical Devices")
Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.
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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-839214700-topical_medicine_cream_ssd]( "Semi-Solid And Semi-Liquid Dosage Forms: What To Know")
Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.
TRANSDERMAL DRUG DELIVERY SOLUTIONS
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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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![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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![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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![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."
