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The FDA released a draft guidance for the development of drugs that use nanomaterials, emphasizing that quality, efficacy and safety of products containing nanomaterials can be sensitive to the production environment and manufacturing process. Read More
ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The FDA issued a warning letter to Fresenius Kabi for GMP violations observed at its manufacturing facility in Himachal Pradesh, India, citing a failure to investigate sterility issues. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More