Validation and Compliance

Sep 01, 2010
BioPharm International
Too many REMS cause headaches for doctors and the industry.
Aug 01, 2010
BioPharm International
Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.
Jul 01, 2010
BioPharm International
More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.
Jul 01, 2010
BioPharm International
By BioPharm International Editors
By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.
Jun 01, 2010
BioPharm International
International outsourcing and rising theft spur regulatory action and manufacturer oversight.
May 01, 2010
BioPharm International
Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.
Apr 01, 2010
BioPharm International
The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.
Mar 01, 2010
BioPharm International
The new Sentinel system aims to expand access to data on medical product safety and patient effects.
Mar 01, 2010
BioPharm International
By BioPharm International Editors
An effective CAPA plan provides a mechanism for responding to the unexpected.
Feb 01, 2010
BioPharm International
Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.
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