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FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form
In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of
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Clinical Trial Accrual Hampered by Many Factors
In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician
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Clinical Research Regulation: FDA vs. ICH
On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90),
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The Historical Rise of Pharmaceutical Regulation
The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers
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Time Management for the Research Professional
It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development.
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Latin Abbreviations Ad Nauseam
In case your Latin is a little rusty, here's a list of abbreviations commonly used in medical charts and prescriptions.
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Surviving an FDA Inspection of Your Clinical Trial Site
The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA)
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Consulting is an Art
...or Why I'm Not a Singing CRA. During those confusing and wondrous years, when a young man ponders his career
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Illuminating the Diagnosis of Intracranial Hematoma
Without urgent pressure-relieving surgery, the chance of survival drops quickly for head trauma patients having a severe intracerebral hematoma (bleeding
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FDA’s Bioresearch Monitoring (BIMO) Inspections
BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality
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