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The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

The PharmTech Group editors present our most popular interviews from 2024.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.