Stability Considerations for Drug-Device Combination Products-21 CFR Part 4 Update

Created by: Chris Latoz & Kim Huynh-ba Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a […]

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Created by: Chris Latoz & Kim Huynh-ba Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a […]
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