FDA - Annual report on the State of Pharmaceutical Quality

3rd September 2025

The annual report on the State of Pharmaceutical Quality is intended to help characterise the quality of the U.S. drug supply chain. Released 2nd Sept 2025 by FDA.

It is updated each year to provide current and cumulative data about pharmaceutical manufacturers, their products, and postmarket quality defects. In addition, this report provides insights about import alert additions, recalls, and warning letters.  The report also highlights emerging approaches to surveil, characterise, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

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