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October - December 2011

John Avellanet

Reading the FDA Tea Leaves

by John Avellanet
Management Director, Cerulean Associates, LLC

As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable future—of the trends shaping agency action. These actions may include the issuance of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?

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Holly Scott

What to Expect When They're Inspecting - Part I

by Holly Scott
Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

One expects variations in the level of coverage at firms in different program areas, whether it's drugs, devices, biologics, dietary supplements, clinical research, or a food firm, because each industry area is so technically diverse. However, observation methods used by Investigators should be comparable and not diverge significantly. If two firms are manufacturing the same regulated product, and are both undergoing a routine GMP inspection, why does one receive an FDA-483 citation for an observation while the second firm receives no citation although the same observation was made? Is it a lack of continuity between Investigators, or are there other contributing factors?

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Marie McKenzie Mills

Is There a Legal Requirement to Have SOPs for GCP in Europe?

by Dr. Marie McKenzie Mills
MICR, CSci, CBiol, MSB

As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

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Did you know that a discovery has opened new options for improving blood transfusions? Donated red blood cells lose a key feature that diminishes their lifesaving power the longer they have been stored, according to researchers at Duke University Medical Center. The finding, published in the journal Critical Care Medicine, details how banked blood undergoes a change during storage that decreases its ability to transport oxygen.
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