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.
As COVID-19 leads to new supply chain difficulties, the FDA wants more information on shortages
Amid potential shortages of drug products resulting from the COVID-19 outbreak, the FDA issued new guidance updating policy on how and when manufacturers should notify
FDA policy to permit compounding of hydroxychloroquine could address COVID-19 shortages
Compounders have gotten the all-clear to make hydroxychloroquine sulfate and chloroquine phosphate using bulk chemicals, a move intended to address emerging shortages of the drugs during the COVID-19 pandemic.
The twenty-two regulatory pathways the FDA is likely to leverage to get new COVID-19 therapies to patients
The FDA has more than 50 regulatory pathways available to companies hoping to get a new drug or biologic approved. Here are the 22 that
FDA adapts policies to allow greater distribution of personal protective equipment
New guidance from the FDA will permit greater production and distribution of personal protective equipment by non-healthcare companies. The policy could help alleviate a shortage of the essential equipment needed to respond to COVID-19.
With shortages looming, the FDA allows unprecedented flexibility for marketing respirators and masks
New FDA policies to permit reprocessing respiratory equipment and allowing unapproved or uncleared devices on the market represent a changing dynamic under the agency’s traditionally risk-averse framework.
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.
Does the FDA need a COVID-19 Advisory Committee?
As the FDA prepares to review drugs and biologics intended to treat, cure or prevent COVID-19, it will soon need to decide whether to make
How the CARES Act would affect life science regulatory policy and the FDA
The $2.2 trillion Coronavirus Aid, Relies and Economic Security (CARES) Act contains several regulatory provisions important to FDA-regulated industries. AgencyIQ explains these provisions and their potential impact.
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.
FDA outlines new regulatory approach for convalescent plasma to treat COVID-19
A new policy from the FDA aims to expedite the use of “convalescent plasma” to help treat patients affected by COVID-19. But as AgencyIQ explains, there are still rigorous requirements that could limit the use of the therapy for large numbers of patients.
To increase supplies of ventilators, FDA offers new flexibility to manufacturers
As the White House reports that car and technology companies have been given the go-ahead to begin manufacturing complex medical devices like ventilators, the FDA issues new guidance on what those companies would have to do to start manufacturing.
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.
As public health infrastructure battles COVID, the FDA transforms
After a slow start, the FDA is furiously trying to respond to a disease outbreak with every tool at its disposal. But will it be enough?
FDA offers new flexibilities on adverse event reporting to life sciences companies
The FDA is offering life sciences companies additional flexibility to report adverse events about their products as the industry grapples with the effects of the novel coronavirus and its impact on the availability of their staff. Here’s what companies need to know about reporting in the time of COVID-19.
