FDA officials, drug developers discuss how to streamline safety monitoring for biologics
FDA officials, academic researchers and drug developers gathered at the FDA’s headquarters on Monday to discuss the landscape for monitoring the safety and efficacy of biologic drugs.
The FDA, in collaboration with the American Association of Pharmaceutical Scientists, held the day-long public workshop in Silver Spring, MD, to glean ways to tackle what’s known as therapeutic drug monitoring — a method used by clinicians to track drug levels in a person’s bloodstream. The practice is frequently used to determine optimal doses, especially for drugs that can be easily under- or over-dosed.
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