Newsletter | March 9, 2023

03.09.23 -- FDA, FTC Collaborate To Advance Biologics Competition

Featured Editorial
Industry Insights
Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

Regulatory Considerations For Alternative Microbial Methods

This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

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