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Emergency Response

August 14, 2020 | Daily News

Third-party medical device servicers say they support Senate Finance Committee ranking Democrat Ron Wyden’s (OR) bill that would allow independent service organizations to repair medical devices for the duration of the COVID-19 emergency, though they would like to see the language extended beyond COVID-19.

August 13, 2020 | Daily News

HHS’ new $6.5 million investment in two commercial diagnostic laboratories aims to expand the U.S. testing capacity by 1 million tests per week by utilizing excess supply and expanding the lab workforce, according to Brett Giroir, HHS assistant secretary.

August 10, 2020 | Daily News

Top FDA officials say the traditional biologics license application process and emergency use authorization, including possible subpopulation EUAs, are the most likely avenues for COVID-19 vaccine approvals, and they suggest vaccine makers veer away from the agency’s Accelerated Approval program.

August 06, 2020 | Daily News

President Donald Trump will sign a “buy American” executive order Thursday afternoon (Aug. 6) that directs FDA to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability, and target dangerous counterfeit drug and medical product imports.

August 05, 2020 | Daily News

A National Institutes of Health-funded study found that 21 existing drugs show potential in treating COVID-19 patients and four of those medications, coupled with remdesivir, can be repurposed to help block coronavirus infections, NIH Director Francis Collins said in a Tuesday (Aug. 4) press release.

July 30, 2020 | Daily News

As lawmakers and industry experts criticize lack of federal coordination and slow turnaround times on COVID-19 diagnostic tests, HHS Assistant Secretary for Health Brett Giroir asserted that reports of widespread delays in receiving test results are largely inaccurate and that there are no significant problems with securing testing supplies.

July 29, 2020 | Daily News

FDA on Wednesday (July 29) issued a new emergency use authorization template for developing over-the-counter COVID-19 diagnostic tests that can be used outside of a laboratory.

July 28, 2020 | Daily News

Doctors from Detroit’s Henry Ford Health System have yet to hear back from FDA about their emergency use authorization request for the anti-malarial drug hydroxychloroquine, as President Donald Trump continues to tout the drug as a treatment for COVID-19.

July 27, 2020 | Daily News

Senate Republicans’ COVID-19 relief package, introduced Monday (July 27), calls on FDA and the Centers for Disease Control and Prevention to coordinate on efforts to improve and speed development of diagnostic tests, treatments and vaccines for emerging infectious diseases, and to work with stakeholders to identify medical product supply needs for public health emergency response.

July 27, 2020 | Daily News

Senate Judiciary Committee Chair Lindsey Graham (R-SC) and Senate health committee Chair Lamar Alexander (R-TN) introduced bills Monday (July 27) that aim to ramp up domestic procurement and manufacturing of medical products, and provide tax credits to qualifying personal protective equipment manufacturers.

July 22, 2020 | Daily News

The Senate on Wednesday (July 22) rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Donald Trump to invoke the Defense Production Act to provide states with medical equipment, such as tests, respirators, gowns and gloves.

July 20, 2020 | Daily News

Over the weekend, FDA granted the first emergency use authorization (EUA) for a COVID-19 pooling test to Quest Diagnostics.

July 13, 2020 | Daily News

An infectious disease expert working closely with laboratories in Memphis, TN told Inside Health Policy that Poplar Healthcare received an emergency use authorization (EUA) for COVID-19 pool testing on Friday (July 10).

July 10, 2020 | Daily News

A Massachusetts-based nurses union is pushing back on the Trump administration’s calls for health care workers on the frontlines of COVID-19 response to reuse personal protective equipment, including N95 respirators.

July 10, 2020 | Daily News

FDA announced Friday (July 10) it will begin conducting announced domestic facility inspections for the first time since March.

July 09, 2020 | Daily News

The National Institute of Allergy and Infectious Diseases has merged four NIAID-funded clinical trial networks to create a new trial network that will recruit thousands of patients into large-scale clinical trials for investigational COVID-19 vaccines and monoclonal antibody therapies.

July 01, 2020 | Daily News

HHS Assistant Secretary for Health Brett Giroir told reporters Wednesday (July 1) that large-scale batch testing for COVID-19 likely will be in place and “very mature” by the time colleges reopen in August and September.

June 26, 2020 | Daily News

FDA last week told labs they could combine and test multiple patient COVID-19 diagnostic test samples using a new “pooling” technique laid out by the agency in a set of updated testing templates, coming just days before National Institute of Allergy and Infectious Diseases Director Anthony Fauci told The Washington Post that health officials were having “intense discussions” about pivoting to the new testing approach.

June 25, 2020 | Daily News

The Centers for Disease Control and Prevention on Thursday (June 25) updated its list of underlying health conditions that might increase a person’s risk of complications from COVID-19.

June 23, 2020 | Daily News

Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended.