FDA, EMA, and senior officials from the European Commission met to discuss the EU–US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and real-world evidence used for post-authorization monitoring. / read more /
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A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels. / read more /
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data. / read more /
The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization. / read more /
Research is focusing on ways to extend dissolution testing, improve in-vitro and in-vivo correlation, and make real-time release testing a reality. / read more /
Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery. / read more /
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
