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The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. Read More
The FDA issued a warning letter to KVK-Tech for serious violations at its Newtown, Pennsylvania drug manufacturing facility, including lax data integrity and investigations. Read More
Tecentriq is currently approved for treating various forms of non-small cell and small cell lung cancer, PD-L1-positive metastatic triple-negative breast cancer, and certain types of metastatic urothelial cancer. Read More
The FDA issued a warning letter to a Yibin, Sichuan API manufacturer for serious recordkeeping violations related to its crude heparin manufacturing operations. Read More
FDA Commissioner Stephen Hahn offered more details yesterday of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak. Read More
The FDA hit a South Korean drug manufacturer for serious violations at its Chuncheon, Gangwon facility, including lax investigations and testing deficiencies. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. Read More