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As COVID restricts FDA travel, could its quality metrics proposal make a comeback?

After initially receiving negative feedback on its proposal to implement a quality metrics reporting program, the FDA’s proposed 2016 program could represent an effective means to getting around travel restrictions imposed by COVID-19. By Aaron Badida, JDBackground and ContextThe FDA regulates and inspects thousands of manufacturing, distribution, storage and dispensing facilities. While the agency is

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FDA inspections at record lows, reflecting impact of COVID-19

FDA data show that the agency conducted far fewer facility inspections in March 2020 than any other month in the last decade, reflecting the extent to which COVID-19 is impacting some routine regulatory activities.   By Alexander Gaffney, RAC and Kedest Tadesse, MS, RAC The number of FDA inspections of pharmaceutical and medical device

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FDA releases long-awaited guidance on COVID-19 drug development

The guidance, intended to support companies racing to develop treatments for the novel coronavirus, outlines best practices for designing clinical trials that the FDA will consider sufficient to support approval. However, the guidance also notes several areas in which the agency is not yet providing recommendations, indicating that changes are yet to come. By

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The Weekly Review

Welcome to The Weekly Review – a timely recap of AgencyIQ’s coverage of major life sciences regulatory trends and the biggest developments at FDA from the past week. It’s been an unsettling few days for much of the US as the realization dawns on many that things are about to become abnormal for a few months. During this uncertain time, we’ve been exploring how COVID-19 will affect FDA systems, processes, and regulatory approvals. We’ve also been covering profound developments related to the VALID Act, FDA’s new diabetes drug development guidance, and companies’ response to shifting drug importation policy.

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Seven Regulatory Problems Laid Bare by the Coronavirus

Few things expose regulatory fault lines quite like an international medical emergency. For the Food and Drug Administration, the novel coronavirus (SARS-CoV-2) outbreak has exposed several longstanding regulatory issues that could have the potential to substantially impact how the US is able to effectively respond to not only this outbreak, but future emerging threats.

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