Regulatory/GMP Compliance

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.
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 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.
Jun 22, 2018
By BioPharm International Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 21, 2018
By BioPharm International Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
Jun 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
Jun 15, 2018
BioPharm International
Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
Jun 15, 2018
BioPharm International
An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.
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