Newsletter | August 14, 2024

Best of July: Top 5 Insights In Clinical Supply Chain & Logistics

Clinical Supply Leader

TOP 5 INSIGHTS IN CLINICAL SUPPLY CHAIN & LOGISTICS  

JULY EDITION

#1 - FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection

The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

#2 - The Present And Future Of Study Supply Management

Gain expert insights on the future of RTSM strategy and its evolution with the changing clinical supply and technology landscape in this on-demand webinar.

#3 - Strategies To Tackle CAR-T Product Challenges

This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

#4 - Optimizing Cell Therapy Supply Chains For Success: Why Outsourcing Expertise Is Critical

When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.

#5 - New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability

A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.