Recent FDA actions and responses on COVID-19 pandemic

By Jenni Spinner contact

- Last updated on GMT

(Marko Geber/iStock via Getty Images Plus)
(Marko Geber/iStock via Getty Images Plus)

Related tags: COVID-19, Coronavirus, Fda, EUA, Clinical trials, Drug development

The US Food and Drug Administration has stayed on top of developments around the pandemic, including research into potential vaccines and treatments.

The drug development industry remains hard at work on treatments, tests, vaccines, and other solutions designed to help combat the COVID-19 pandemic. At the same time, the US Food and Drug Administration has kept its employees occupied with the review of such products, releasing of resources for industry professionals and civilians, and other coronavirus-related activity.

FDA’s plan of action

Acting FDA commissioner Janet Woodcock recently testified before the Senate Committee on Health, Education, Labor, and Pensions. Her testimony (in a hearing titled “The Path Forward: A Federal Perspective on the COVID-19 Response”​) offered updates on the agency’s progress in numerous areas, as well as plans for response over the coming months.

OSP_FDA072621_JW
Janet Woodcock, acting commissioner, US Food and Drug Administration

From the beginning of this public health emergency, FDA has taken an active leadership role in the all-of-government response to the COVID-19 pandemic, inspired by the resiliency of the American people and our great innovators​,” Woodcock testified. “FDA stood up an internal cross-agency group that continues to ensure we are doing everything possible to protect the American public, help ensure the safety, efficacy, and quality of FDA-regulated medical products, and provide the industries we regulate with the guidance and tools to do the same​.”

Her testimony touched upon:

  • Biologics and vaccines research, evaluation, and approval
  • Expediting of COVID-related clinical research
  • Expedited review of EUA requests
  • Work of the Coronavirus Treatment Acceleration Program (CTAP) to get therapies evaluated and approved as quickly as possible

Woodcock’s full Congressional testimony can be found here.

At-a-glance response summary

The FDA has updated its FDA COVID-19 Response At-A-Glance Summary document​. The resource is intended to keep drug developers, researchers, healthcare providers, and civilians apprized on the actions taken and information issued by the agency.

The document includes information on:

  • Emergency use authorizations (EUAs) issued for COVID-19 tests; to date, 396 tests and sample-collection devices have received EUAs
  • Running tally of drugs currently being investigated as potential COVID-19 treatments—according to the FDA, there currently are more than 630 drug development programs in planning stages and 11 EUAs issued for COVID-19 treatments
  • Revisions and updates to patient-provider fact sheets on approved COVID-19 vaccines
  • Updates on drug shortages impacted by the pandemic.

Unauthorized COVID-19 consumer products

The FDA continues to monitor the sale and distribution of products to the public that are purported to prevent, treat, or cure COVID-19 infections. Companies recently issued warning letters for selling unapproved products include:

  • Jordan’s Crossing Herbal Connections
  • Halodine LLC
  • Amplicon Land LLC

Related news

Show more

Related products

show more

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 20-Jun-2022 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Multiple Sclerosis Analytical Report

Multiple Sclerosis Analytical Report

PatSnap | 15-Jun-2022 | Technical / White Paper

More than 2.3 million people are living with MS worldwide. Although there is no cure, new research and innovative treatments are continuously emerging....

Strategic Approach to Immunogenicity Assessment

Strategic Approach to Immunogenicity Assessment

Altasciences | 17-May-2022 | Technical / White Paper

In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity...

Governing and Maintaining Clinical Data Standards

Governing and Maintaining Clinical Data Standards

Veeva | 10-May-2022 | Technical / White Paper

Investing in data standards plays a huge role in improving the quality of clinical studies. But often, people don’t use the standards correctly, there...

Related suppliers

Follow us

Products

View more

Webinars