Newsletter | September 13, 2025

09.13.25 -- Pharmaceutical Online Best Of August

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Webinar: Not All Manufacturing Automation is Created Equal: Implementing Outcome-Based Strategies to Drive Real Results

Join this webinar to learn how outcome-based automation drives measurable improvements in life sciences manufacturing. Discover how aligning digital tools with business goals enhances efficiency, reduces risk, and improves cross-functional performance. Key takeaways include: the impact of automation on critical outcomes, strengthening data integrity, and strategies to reduce complexity while maximizing ROI from automation initiatives. Click here to learn more.

AUGUST'S BEST FEATURED EDITORIAL

President Trump Demands MFN Prices In Manufacturer Letters

President Trump has sent out a letter to 17 major pharmaceutical manufacturers, asking them to commit to lower prices by Sept. 29, 2025, or he plans to deploy every tool in his arsenal to protect American families.

FDA Publishes 200+ CRLs For Increased Transparency

The letters were made available to increase transparency and help sponsors reduce similar mistakes in the future.

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." 

AUGUST'S BEST INDUSTRY INSIGHTS

The Impact Of AI In Biopharmaceutical Manufacturing

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

ISO Cleanroom Standards

Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

21 CFR Part 11 Data Management Is The Basis Of Data Integrity

Learn about FDA regulation 21 CFR Part 11 and the critical role it plays in ensuring pharmaceutical and medical product manufacturers properly manage and track their data.

AUGUST'S BEST SOLUTIONS

Automated Media Fill Microbial Inspection

Cleanroom Compliance Is Easy With The Capability To Run Quick Reports

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

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