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The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars. Read More
An FDA inspection of Isometric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter. Read More
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Read More
Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s India plant in December 2016. Read More
The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Read More