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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The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form. Read More
Modified-release products containing paracetamol will be suspended from the market in the European Union, the European Medicines Agency announced. Read More
The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form. Read More
The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit. Read More
PhRMA announced it is partnering with the Addiction Policy Forum as part of a “multi-year, multi-million dollar” initiative to address opioid addiction. Read More
The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More