Quality Systems

Jul 01, 2018
BioPharm International
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
Jul 01, 2018
BioPharm International
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
Jul 01, 2018
BioPharm International
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jul 01, 2018
BioPharm International
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
Jun 28, 2018
By BioPharm International Editors
The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.
Jun 27, 2018
By BioPharm International Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 25, 2018
By BioPharm International Editors
GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.
Jun 25, 2018
By BioPharm International Editors
The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.
Jun 22, 2018
By BioPharm International Editors
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.
Jun 22, 2018
By BioPharm International Editors
The agency launched a secure online portal for orphan drug designation applications.
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