Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies in assigning jurisdiction for premarket review and oversight. In ...
Introduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and marketing them as a “medicinal product” to seek a No
21 CFR part 4viiilists the requirements for a combination product and there are a number of issued US FDA guidance documents and draft guidance documents that elaborate on the possible paths to take for a dossier submission. The preferred approach, when considering converting a vial packaged d...
Technological advancements in drug eluting products offer medical device manufacturers and pharmaceutical companies the opportunity to develop smaller, less invasive, and more effective products. Silicone materials provide many advantages and are commonly used in drug delivery applications, but alternative polym...
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With modern technology and medicine, the combination product market is evolving. Any combination device, especially drug device combination devices, must follow strict guidelines. Thanks to advancements in engineering, an increasing number of drug delivery devices are being developed as electromechanical dev...
“The fundamental principles underpinning drug product component and device component guidance are broadly aligned,” EBE said. “Since the building blocks for product development are already in place, adapting and clarifying Module 3 (MAA quality) content for DDC products should be possible with minim...
Last, the issues which the FDA and applicants are dealing with as the process of regulation of new technology continues to develop and change, with some insight into FDA action plans to address these complex issues.J. GREENBAUMDrug-Device Combination Products...
Innovate, Improve & Implement: Drive Engagement, Sustainability & Accessibility of Drug Delivery Devices & Combination Products. Revolutionise treatment with patient centric approaches, novel delivery mechanisms & digital health devices. November 9-10,
Drug manufacturers and distributors submit documentation about their products to FDA in the Structured Product Labeling (SPL) format. The openFDA drug product labeling API returns data from this dataset. Drug NDC The openFDA drug NDC Directory endpoint returns data from the NDC Directory, a databas...