Quality Systems

Jul 01, 2003
BioPharm International
FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents
Jul 01, 2003
BioPharm International
By BioPharm International Editors
A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.
Jul 01, 2003
BioPharm International
By BioPharm International Editors
In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
Mar 18, 2003
By BioPharm International Editors
The Pharmaceutical Business is Incredibly Complex. Reaching Every Part of it Doesn't Have to Be.
Feb 01, 0004
BioPharm International
FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.
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