Newsletter | August 1, 2025

08.01.25 -- CDER's Director Set To Retire Amid FDA Leadership Shuffle

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Webinar: How Compliance-Driven CDMOs Win Sponsor Contracts

In today's sciences landscape, compliance is no longer just a requirement, it's a competitive advantage. This MasterControl webinar explores how evolving global regulatory frameworks are reshaping sponsor expectations and increasing CDMO risk. Learn how digitally mature manufacturers can embed compliance into daily operations, avoid costly disruptions, and gain strategic edge in client audits, contract renewals, and market access. Click here to learn more.

INDUSTRY INSIGHTS

 

The Impact Of AI In Biopharmaceutical Manufacturing

From automating repetitive tasks to optimizing complex bioprocesses, AI is reshaping biopharmaceutical manufacturing. See how AI is moving beyond trends to become a foundational element in the industry.

 

The GxP AI Podcast: Unveiling the AI Model Validation Cheat Sheet

Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.

 

The Hidden Costs Of Equipment Storage: What You're Really Paying For

Don't let idle assets drain your resources. Uncover the often-overlooked expenses of equipment storage, from rental fees to lost opportunity costs, and learn how to reclaim value.

 

Mixing Technology Considerations For The Cannabis And CBD Industries

Explore an array of mixers and mixing technologies that can help you throughout the cannabis product manufacturing process.

 

21st Century Manufacturing Of Injectable Pharmaceuticals

Find out how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.

 

Powering Drug Development With Advanced AI Retrosynthetic Analysis Tools

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

 

Specific Sterilization Method: Best Practices And Common Pitfalls

Validating sterilization methods like steam, VH₂O₂, and EO is essential for safety and compliance. Learn best practices, avoid common pitfalls, and optimize your validation strategy effectively.

 

Faster Timelines, Lower Costs, And High-Quality Processes

The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

 

The Role Of CDMOs In Supporting Generic Drug Development

Bringing complex generics to market requires deep expertise. Gain insight into how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end support.

 

Why Project Management Is Essential To CDMO Partnerships

Read about why strong project management is vital to biotech success—and how the right CDMO partnership can prevent costly delays and keep your development timelines on track.

 

HPAPI Processing And Drying Suite For Operator And Product Protection

A two-part enclosure consisting of a single pass airflow glove box enclosure and a nitrogen purge enclosure was designed to provide protection to the operator and product.

FEATURED EDITORIAL

CDER's Director Set To Retire Amid FDA Leadership Shuffle

Jacqueline Corrigan-Curay, M.D., J.D., announced plans to retire from her position as acting director of CDER, calling the decision "incredibly challenging." Corrigan-Curay is not alone in her decision to leave the FDA, with a number of leaders exiting the agency since January.

 

SOLUTIONS

Unlocking Pharmaceutical Success: From Idea To Reality

Cleanroom Compliance Is Easy With The Capability To Run Quick Reports

Automated Media Fill Microbial Inspection

Does Blow/Fill/Seal Aseptic Packaging Make Sense for Your Drug?

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