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By Edwin Bills, Christie Johnson, and Jayet Moon | On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more. |
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| Spray Drying To Enable New Inhaled Drug Products | White Paper | By Lliralyn M. McEachern, Thomas S. Lund, and Alan B. Watts, Ph.D., Catalent | The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or a rapid onset therapeutic. |
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| Developmental Testing Of IV Solutions | Article | By Ryan Memmer, Singota Solutions | As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration. |
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| Why KinetiSol Is Disrupting Spray Drying | Webinar | AustinPx | Review a process not only capable of reproducing spray-dried dispersions with less complexity and environmental impact but also with the capability to out-design and outperform spray drying. |
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| Combining Gene Therapies, Carrier Systems, And Medical Devices | Article | By Stefanie Johns, Ph.D., Kymanox Corporation | 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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