Standards/Regulations

Sep 28, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 25, 2017
By BioPharm International Editors
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Sep 21, 2017
By BioPharm International Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 19, 2017
By BioPharm International Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 12, 2017
By BioPharm International Editors
The agency is looking for industry input on best practices for continuous manufacturing.
Sep 01, 2017
BioPharm International
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Sep 01, 2017
BioPharm International
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Aug 28, 2017
High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
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