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The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed, in anticipation of the November launch of a mutual agreement between the EU and U.S. Read More
The FDA sent warning letters to four compounding pharmacies, reminding them of their obligations under federal law to compound drug products based on valid prescriptions, while one compounder told the agency it was exempt from the FDA’s GMP requirements. Read More
The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More
Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More