1
Jul.
31, 2025
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
The purpose of this guidance is to provide FDA’s current thinking on 1) management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and 2) comparability studies to assess the effect of manufacturing changes on product quality.
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2
Jul.
31, 2025
Guidelines for Selecting PETG Media Bottles and Managing Precipitates
In daily laboratory work, PETG media bottles play an indispensable role as essential containers for storing and transferring liquids. This article provides an in-depth discussion on the material properties, common specifications, types of precipitates, and their management methods to help researchers better select and use PETG media bottles, ensuring smooth experimental procedures.
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3
Jul.
31, 2025
Advantages of Flexible, Stand-Up Pouches Over Traditional Pouches
Consumer demand confirms that stand-up pouches align perfectly with today’s convenience-driven lifestyle. These pouches make dispensing easier and provide better storage functionality than traditional pillow packs, which lack the ability to stand upright and are more prone to spills.
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4
Jul.
31, 2025
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
In this guidance, we, FDA, provide recommendations for studies that evaluate multiple versions of a cellular or gene therapy product, including how to organize and structure the INDs, submit new information, and report adverse events. This guidance finalizes the draft guidance of the same title dated September 2021.
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5
Jul.
31, 2025
Understanding the Key Differences Between MAP Lidding Films and Traditional Packaging Films
Packaging plays a crucial role in delivering products safely while retaining quality. In recent years, the shift towards Modified Atmosphere Packaging (MAP) has raised many questions among consumers and manufacturers alike. Understanding the differences between MAP lidding films and traditional packaging films is essential for maximizing product lifespan and consumer satisfaction. MAP lidding
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6
Jul.
31, 2025