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June 14, 2019
SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.
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 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 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 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.
Discussing supply chain risk and security as a business led journey, Roddy Martin, chief digital strategist at TraceLink, explains the five stages of its evolution.
Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
May 31, 2019
Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.