Category Archives: Clinical Trials

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FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both … Continue Reading

Breaking Down FDA’s New Remote Monitoring Strategy

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered … Continue Reading

PhRMA Revised Clinical Trial Principles

Pharmaceutical Research and Manufacturing of America (“PhRMA”) has revised its Principles on Clinical Trials to further reflect its commitment to transparency in clinical trials and build upon FDAAA requirements. PhRMA’s updated principles trial address four key issues: protecting research participants; conduct of clinical trials; ensuring research objectivity; and providing clinical trial information. The PhRMA Principles on Conduct of … Continue Reading
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