Regulatory/GMP Compliance

Nov 01, 2008
BioPharm International
The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.
Oct 01, 2008
BioPharm International
Despite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree.
Oct 01, 2008
BioPharm International
The FDA's QbD pilot program is supporting good manufacturing on a global basis.
Oct 01, 2008
BioPharm International
The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems—in the emergency room, because they have no access to routine and preventive care.
Sep 01, 2008
BioPharm International
The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
Sep 01, 2008
BioPharm International
Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.
Sep 01, 2008
BioPharm International
The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.
Sep 01, 2008
BioPharm International
By BioPharm International Editors
Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
Aug 01, 2008
BioPharm International
The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.
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