Standards & Regulations

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 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Sep 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 19, 2017
By Pharmaceutical Technology Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 15, 2017
By Pharmaceutical Technology Editors
European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.
Sep 15, 2017
By Pharmaceutical Technology Editors
The approval marks the first biosimilar approved in the United States for treating cancers.
Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 12, 2017
By Pharmaceutical Technology Editors
The agency is looking for industry input on best practices for continuous manufacturing.
Sep 12, 2017
By Pharmaceutical Technology Editors
The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.
Sep 11, 2017
By Pharmaceutical Technology Editors
FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
native1_300x100
lorem ipsum