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Emergency Response

September 04, 2020 | Daily News

A group of Democratic representatives want three major commercial laboratories to increase pooled testing for COVID-19, specifically in New Jersey, New York and Connecticut, in order to increase testing output while preserving critical supplies.

September 02, 2020 | Daily News

The American Nurses Association wants the Trump administration to invoke the Defense Production Act for N95 masks to help resolve shortages of masks and other personal protective equipment, which it says would help cut down on the reuse and decontamination of masks that are intended only for single-use.

September 01, 2020 | Daily News

The National Institutes of Health (NIH) said Tuesday (Sept. 1) that convalescent plasma, an investigational COVID-19 therapy touted by the White House, lacks data to prove its effectiveness and should not be considered standard of care for COVID-19.

August 31, 2020 | Daily News

The House Energy & Commerce Committee announced Monday (Aug. 31) that it will hold a public hearing with FDA chief Stephen Hahn in September, coming after committee heads held a phone briefing with Hahn and other top agency officials to address the agency’s response to the COVID-19 pandemic and FDA’s reputation as an independent agency.

August 31, 2020 | Daily News

Drug and device industry lawyers are surprised that FDA’s latest inspection guidance fails to expand on whether and how the agency will use remote technologies to conduct facility inspections during the COVID-19 pandemic.

August 28, 2020 | Daily News

A group of Democratic senators wrote to FDA Thursday (Aug. 27) requesting whether the agency is tracking adverse events and monitoring the use of hydroxychloroquine in COVID-19 patients after state reports revealed some nursing home residents were given the investigational therapy without proper authorization or consent.

August 28, 2020 | Daily News

Sen. Elizabeth Warren (D-MA) wrote to FDA Thursday (Aug. 27) asking how it notifies medical providers when emergency use authorizations are revoked or changed, and whether there are consequences for companies or providers that continue to distribute and use products after an EUA is revoked.

August 27, 2020 | Daily News

FDA on Thursday (Aug. 27) issued its first emergency use authorization (EUA) to a COVID-19 antigen test where the results can be read directly from the testing card, similar to a pregnancy test.

August 26, 2020 | Daily News

A rapid point-of-care breath test for COVID-19 could be commercially available by the fall of 2020, the ECRI Institute asserts in a report published Wednesday (Aug. 26).

August 26, 2020 | Daily News

FDA chief Stephen Hahn has not responded to Senate Republicans’ requests for more information on why the agency decided to revoke emergency use authorization for hydroxychloroquine and chloroquine in June, and then to subsequently reject Henry Ford Health System’s request to reissue the authorization.

August 25, 2020 | Daily News

After the Trump administration moved to cut FDA out of regulation of laboratory-developed diagnostic tests, the leading medical device lobby Advanced Medical Technology Association encouraged its members to continue to validate their tests with the agency before entering the market and vowed to continue working with Congress on legislation to set up a new diagnostic regulatory framework to make tests more readily available to patients.

August 23, 2020 | Daily News

President Donald Trump and FDA chief Stephen Hahn announced Sunday evening (Aug. 23) that the agency has granted emergency authorization to convalescent plasma for use as a COVID-19 therapy, after top health officials had recently delayed the EUA.

August 21, 2020 | Daily News

Phoenix Biotechnology, the company behind the controversial push to use the botanical extract oleandrin as a COVID-19 cure, tells Inside Health Policy the company is pursuing a “multitude of different angles” at FDA to bring the product to market, coming as President Donald Trump touts the botanical but leading scientific experts cast doubt on its effectiveness as a COVID-19 treatment and cite potential health risks.

August 21, 2020 | Daily News

John Hopkins’ Center for Health Security proposed a temporary COVID-19 vaccine framework that suggests the initial limited supply of a potential vaccine be distributed to frontline health care workers, individuals with high risk of death and essential workers.

August 20, 2020 | Daily News

House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) demanded a briefing from HHS Secretary Alexander Azar on why the department decided it will no longer require laboratory developed tests to undergo FDA premarket reviews before coming to market.

August 20, 2020 | Daily News

FDA will no longer require premarket review for laboratory developed tests, including tests developed to diagnose COVID-19, HHS announced Wednesday (Aug. 19).

August 20, 2020 | Daily News

President Donald Trump touted donated convalescent plasma as a cure for COVID-19 at a news conference Wednesday evening (Aug. 19) during which he confirmed FDA was “on the brink” of issuing an emergency use authorization before being derailed by health officials that the president alleged might have wanted to delay action till after Nov. 3 for political purposes.

August 19, 2020 | Daily News

HHS Assistant Secretary Brett Giroir praised a newly approved COVID-19 rapid point-of-care test for its low cost, quick turnaround time and flexible platform that will help give patients a quicker diagnosis, as well as possibly help scale up testing and increase patient access to care.

August 17, 2020 | Daily News

Despite reassurance of "excess" COVID-19 testing supplies from the White House, FDA revealed in its first medical device shortage list posted late Friday (Aug. 14) that there are shortages of COVID-19 testing equipment such as swabs, reagents, storage and transport devices and instrumentation systems due to the public health emergency

August 17, 2020 | Daily News

FDA gave its first emergency authorization for a saliva-based COVID-19 diagnostic test that does not require any special swab or collection device on Saturday (Aug. 15) in the hopes of increasing testing capacity and reducing the current strain on testing equipment.