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June 14, 2019
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.
June 13, 2019
Vida International received an FDA warning letter after an inspection found quality control violations.
June 11, 2019
The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.
June 10, 2019
Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.
June 07, 2019
Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.
June 06, 2019
EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.
Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.
June 05, 2019
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
June 02, 2019
FDA’s annual manufacturing report card shows more quality compliance is needed.
The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.