FDA COVID-19 advice and announcements this week

By Jenni Spinner

- Last updated on GMT

(RomeoLu/iStock via Getty Images Plus)
(RomeoLu/iStock via Getty Images Plus)

Related tags Fda COVID-19 Coronavirus Testing Gilead

The latest coming from the agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

The latest coming from the US federal agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

While the COVID-19 virus rages on and infections continue to climb in the country, the US Food and Drug Administration (FDA) has maintained its status as a resource for life-sciences professionals working on treatments and diagnostics.

First approved treatment

Approximately seven months after the World Health Organization (WHO) officially declared COVID-19 a pandemic, the FDA approved its first drug for treatment of the virus​. Gilead’s Veklury (remdesivir) is an antiviral drug indicated for hospitalized patients diagnosed with the virus.

According to FDA commissioner Stephen Hahn, the agency is focused on supporting development and distribution of treatments for the virus.

As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks​,” he said.

Insights and voices

The FDA has released various resources with agency leaders sharing perspectives and updates. The latest FDA Insight podcast, featuring deputy commissioner Anand Shah and director of FDA's Center for Biologics Evaluation and Research Peter Marks, summarizes key points of the recent Vaccines and Related Biological Products Advisory Committee meeting.

Additionally, the latest FDA Voices blog includes input from Marks on the FDA’s role in facilitating development of COVID-19 vaccines. Marks discusses the value of discussing data with members of the Vaccines and Related Biological Products Advisory Committee in helping to build trust and confidence in their use.

Antigen template

The FDA updated the Antigen Template for Test Developers, which is designed to give developers current agency recommendations concerning data and information that should be submitted to the agency in support of an EUA request for a SARS-CoV-2 antigen test.

The most recent update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests. The template is intended to reflect the FDA’s current thinking on the topic and should be viewed only as recommendation, unless specific regulatory or statutory requirements are cited.

Fraudulent COVID-19 products

The agency has not to date approved any products intended for direct sale to the public for diagnosis, treatment or cure of COVID-19. However, that has not stopped scores of unscrupulous manufacturers for attempting to pass off such products and sell them off shelves or online.

Most recently, the agency issued a warning letter (issued jointly with the Federal Trade Commission) to For Our Vets LLC, doing business as Patriot Supreme, for selling unapproved COVID-19 products. The company’s unauthorized wares include CBD products, promoted with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19.

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers