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.
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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.
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.
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.
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.
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?
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.
Following reports that alcohol-based hand sanitizer is increasingly difficult to find, the FDA says it will temporarily allow other manufacturing entities—including distilleries—to make hand sanitizer.
The outbreak of the novel coronavirus has increased scrutiny of how diagnostic devices are regulated in the US. Two new legislative proposals would enact very different reforms. AgencyIQ explains what’s at stake and how the proposals would work.
Two federal statutes—one overseen by the FDA and the other not—could help to facilitate more rapid access to investigational medical products meant to treat COVID-19. But as interest in the programs expand, so too will the pressure on regulators and companies to deliver both results and products to patients. There are significant trade-offs to consider.
As COVID-19 continues to affect the agency, several advisory committee meetings have been postponed or cancelled. As AgencyIQ’s analysis indicates, while the impact on a small number of products could be large, advisory committees are not used as often as they once were, mitigating the broader impacts of the cancellations.
Industry experts told AgencyIQ that ongoing clinical trials, as well as trials that were set to begin enrollment, could be hit hard by ripple effects from the novel coronavirus outbreak. Both industry and the FDA are quickly trying to determine how to adapt trials, protect patients, and save the clinical data needed to support future regulatory decision-making.
Companies are racing to develop treatments and vaccines for COVID. But first, they’ll need to figure out how to test the safety and efficacy of these drugs. Here’s what they might be thinking about in the weeks ahead.
Join the AgencyIQ research team for a conference call on Wednesday, March 25th at 3:00 pm EST for a conference call to discuss the regulatory impact of COVID-19.