Blog

Welcome to the new AgencyIQ blog! We will periodically post important updates and some of our most compelling content here. If you’d like to learn more about AgencyIQ, please e-mail us using the contact us tab. 

 

Welcome!

Welcome to the AgencyIQ blog! AgencyIQ is a new division of POLITICO which provides fresh insight into the FDA and U.S. regulatory environment via in-depth research and an easy-to-use technology platform. We invite you to learn more about AgencyIQ by exploring the “Product” section of this website or by getting in touch with us

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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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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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FDA grants new flexibility for COVID19 testing distribution

An updated policy from the FDA will permit states to validate and oversee the development and distribution of tests to detect COVID-19 without first receiving approval from the FDA, and manufacturers to begin using certain tests before obtaining FDA approval. The extraordinary policy reflects considerable urgency to increase testing capacity in the US in the face of a mounting crisis.

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COVID-19: The Competitive Landscape for Medical Product Development

The pharmaceutical and biopharmaceutical industry is scrambling to put products into development to treat, cure, or prevent COVID-19 infections.

This AgencyIQ analysis, based on a review of ClinicalTrials.gov, company announcements, and media reports, identifies 65 candidates in various stages of testing to assess their effects against COVID-19 or SARS-CoV-2, the virus which causes the condition. These products are already at various stages of development. Some have already been approved and are being assessed for their potential to treat COVID-19, while others are being re-purposed from other late-stage development pipelines. Others are still in the very early stages of development and have not yet been tested in humans.

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FDA grants new flexibility for COVID19 testing distribution

An updated policy from the FDA will permit states to validate and oversee the development and distribution of tests to detect COVID-19 without first receiving approval from the FDA, and manufacturers to begin using certain tests before obtaining FDA approval. The extraordinary policy reflects considerable urgency to increase testing capacity in the US in the face of a mounting crisis.

Read More »