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A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More
FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016. Read More
The FDA hit drugmaker Opto-Pharm with a warning letter, citing a lack of written procedures for preventing contamination of sterile drug products, as well as problems with validation, testing and labeling. Read More
A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More