Newsletter | March 12, 2025

03.12.25 -- Will 2025 Represent A Continuation Of FDA's 2024 Developments?

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Will 2025 Represent A Continuation Of FDA's 2024 Developments?

By Emily Marden and Kelly Cho, Sidley Austin

This article highlights key FDA regulatory considerations for cell and gene therapies in 2024, covering advancements, challenges, and policy shifts shaping the industry. As the regulatory landscape evolves, will 2025 bring a continuation of these efforts, or will new priorities and frameworks emerge to further refine the approval and oversight process?

Ensure Seamless Clinical Trial Transition Across Global Markets

Article | By Alex Kavros, Avance Clinical

If you want to increase speed and reduce costs while still procuring high-quality data for your clinical trial, consider the impact of launching an early-phase clinical trial in Australia.

The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators

Article | Contec, Inc.

Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.

Concentrating And Ultra-High Concentrating Protein Therapeutics

Article | By Anthony Stewart, Kymanox Corporation

By addressing physical instability and high-viscosity issues early when developing ultra-high protein concentration formulations, see how you can reduce costs and improve patient outcomes.

Developing A Comprehensive Regulatory Approach For LNP Drugs

Article | Cytiva

The path to regulatory approval for LNPs demands carefully considered strategies. Learn how developers can overcome regulatory hurdles on the path to approval by adopting proactive and strategic approaches.

Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

Case Study | Germfree

Review the interworkings of a collaboration that yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

Optimizing CAPA For FDA Recall Success: A Roadmap For Professionals

Article | MasterControl, Inc.

Discover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

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June 3-5, 2025 | Boston, MA 
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