COVID-19 Resource Center

In the interest of supporting regulatory professionals addressing the unprecedented public health threat posed by COVID-19, AgencyIQ will be sharing all content concerning the virus and its regulatory implications on this page as the situation evolves in the coming weeks. 


AgencyIQ is a new division of POLITICO which provides regulatory analysis, data, and tools to regulatory affairs professionals in the pharmaceutical, biotechnology, and medical device industries. If you would like to learn more about AgencyIQ, please contact Alec Gaffney (agaffney@agencyiq.com) or Simmi Bhuller (sbhuller@politico.com).

As therapies for COVID-19 begin testing, the FDA prepares to face a “breakthrough” problem

As an increasing number of companies begin to test drugs and biologics for COVID-19, many will be soon be eligible to receive a regulatory acceleration designation known as “Breakthrough Therapy Designation.” Despite the name, many of these products aren’t breakthroughs and aren’t ultimately approved, indicating the potential for the name of the designation to confuse politicians, the public and the press.

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Webinar: The Regulatory Impact of COVID-19 | Apr. 7 at 12:00 pm EST

This webinar, to be hosted on April 7th from 12:00 pm -1:00 pm EST, is designed to address the information needs of regulatory affairs professionals at pharmaceutical, biotechnology, in vitro diagnostic (IVD), and medical device companies, who are on the front lines of combating the unprecedented public health crisis posed by the novel coronavirus. AgencyIQ will assess how regulatory affairs professionals can navigate rapidly-evolving FDA policy and guidance to get products to test for, treat, and vaccinate against COVID-19 to the public.

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AgencyIQ’s COVID-19 Tracker: The Vaccines & Therapies Being Tested

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

Based on a review by AgencyIQ of ClinicalTrials.gov, company announcements and media reports, there are at least 91 candidates in various stages of testing to assess their potential 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 repurposed 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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Pandemics and intellectual property: How the government can impact COVID-19 drug and device development

The US patent landscape seeks to foster growth and innovation—especially in life sciences. But amid a global pandemic, public-private partnerships and government authority can impact an otherwise routine landscape of drug and device development. Here are four laws, regulations and international agreements that have implications for developers in the COVID-19 crisis.

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