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| Join Drug Delivery Leader Live in discussing human factors risk analysis approaches for combination products and medical devices. Central to the conversation will be the FDA’s draft guidance on Use-Related Risk Analysis (URRA) and how this guidance is related to other risk tools, such as a use Failure Mode and Effects Analysis (uFMEA). Secure your spot for this free digital event happening November 13th. |
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By Drug Delivery Leader: Supplier Horizons | Principal Scientist George Mihov and Global Biomaterials Director Lukasz Koroniak from DSM-Firmenich join Supplier Horizons host Tom von Gunden to discuss partnering with pharma on formulation development. Among the topics covered are translational research, materials development, and complex molecules required for biologic-based therapies. |
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Understanding The Change From EPR To EDDO | By Drug Delivery Leader Live | Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)? In this segment of The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, offers his perspective on how the change in terminology clarifies key concepts related to design controls. |
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| Vial Containment Systems Based On Elastomer 4031/45 Gray | Article | By T. Page McAndrew, Ph.D. and Victoria Morgan, West Pharmaceutical Services, Inc. | For a properly-assembled vial containment system, good container closure integrity performance can be achieved with stoppers of a given elastomer, independent of configuration. |
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