FDA roundup of COVID-19 responses

By Jenni Spinner

- Last updated on GMT

(Image: Getty/Evgenii Kovalev)
(Image: Getty/Evgenii Kovalev)

Related tags Fda Coronavirus COVID-19

The federal agency has been busy in recent weeks, taking actions and issuing advice in the face of the global coronavirus pandemic.

In the weeks since the virus first struck the country, the US Food and Drug Administration (FDA) has issued a number of safety alerts, guidances and other responses related to preventing the spread of the disease. Many of these have potential impact on pharmaceutical manufacturing, clinical trial operations and other industry concerns.

According to FDA commissioner Stephen Hahn, the agency and its partners are taking every effort to help the public, patients, healthcare professionals, and manufacturers.

The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak​,” he added.

This week’s actions include an update on the agency’s recommendations regarding specimen collection for COVID-19 testing. According to the FDA, nasal swabs collected from symptomatic patients would just as effective collected from just the front of the nasal cavity than its depths; this would provide for greater ease, efficiency and comfort on sample collection.

The agency’s Oncology Center of Excellence also advised the medical community that cancer patients are potentially immunocompromised and therefore stand a greater risk of contracting the virus. Center leadership announced they are focused on addressing the critical needs of patients with cancer and their health care providers.

The FDA also provided information on issuance of emergency use authorization (EUA) for virus diagnostic tests. To date, the agency announced it has worked with more than 160 test developers with applications submitted to make COVID-19 diagnostic tests. So far, 15 EUAs have been issued. The FDA has been notified by more than 65 laboratories.

Last week, the FDA issued a guidance document featuring advice regarding operating clinical trials​. The document outlines difficulties and concerns sites and sponsors likely are facing during the pandemic, including travel bans, quarantines, supply chain interruptions and other considerations.

Earlier in March, the agency took measures to help expedite development of diagnostic tests for COVID-19​. The purpose of the test is to increase nationwide testing capacity and expedite development of such tests.

Related news

Show more

Related products

show more

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Lonza Small Molecules | 28-Mar-2023 | Technical / White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Are You Prepared to Meet the New FDA Guidelines?

Are You Prepared to Meet the New FDA Guidelines?

Elligo Health Research® | 23-Mar-2023 | Insight Guide

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 10-Mar-2023 | Technical / White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Elligo Health Research® | 10-Mar-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

Related suppliers

Follow us


View more