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Emergency Response

November 16, 2020 | Daily News

Moderna on Monday (Nov. 16) said that in the coming weeks, it will submit an emergency use authorization request to FDA for the company’s investigational COVID-19 vaccine, which demonstrated 94.5% efficacy in an early analysis of trial data.

November 12, 2020 | Daily News

A recently developed FDA risk assessment tool shows that while N95 masks are the most effective at protecting the wearer from COVID-19 viral droplets, homemade facial coverings still help flatten the COVID-19 curve.

October 28, 2020 | Daily News

FDA has indicated that it might not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization, but there’s a lack of clarity about the agency’s alternative approaches to site inspections.

October 26, 2020 | Daily News

HHS and FDA are once again clashing over laboratory-developed tests. An HHS official tells Inside Health Policy that labs can still voluntarily seek emergency use authorization of COVID-19 LDTs to get liability protection even though the department axed FDA’s regulation of the tests in August, but FDA told labs on Oct. 7 it would no longer accept voluntarily submitted EUAs for the tests.

October 26, 2020 | Daily News

FDA updated its COVID-19 antigen test template Monday (Oct. 26) to recommend certain test developers seeking emergency use authorization include studies to support claims for screening asymptomatic patients, point-of-care testing and tests measuring multiple infections.

October 13, 2020 | Daily News

CMS announced that, since August, it has sent 171 cease-and-desist letters to labs that the agency says are not properly certified, a move that a medical device lawyer asserts could be an attempt by CMS to increase public trust in laboratory-developed tests in light of HHS’ controversial move to scrap FDA oversight of LDTs, including for COVID-19.

October 08, 2020 | Daily News

FDA on Wednesday (Oct. 7) quietly updated its COVID-19 testing frequently asked questions webpage to say it will no longer review emergency use authorization requests for laboratory-developed tests for COVID-19.

October 07, 2020 | Daily News

President Donald Trump announced in a video posted on Twitter Wednesday (Oct. 7) that he has authorized FDA to grant emergency use authorization to experimental COVID-19 antibody cocktails developed by Regeneron and Eli Lilly, adding that they’ll be distributed to patients at no cost.

October 02, 2020 | Daily News

During a congressional hearing Friday (Oct. 2), HHS Secretary Alex Azar defended the Trump administration’s involvement in public health agency decisions, including White House efforts to alter or block reports and guidances, asserting that some of the actions taken are “perfectly normal” and that lawmakers are over-reacting.

October 01, 2020 | Daily News

FDA on Wednesday (Sept. 30) authorized OralDNA Labs’ oral rinse COVID-19 diagnostic test, which the company asserts could help resolve supply chain bottlenecks, coming as FDA officials express concern about potential supply shortages heading into flu season.

September 30, 2020 | Daily News

FDA biologics center director Peter Marks doubled down on the agency’s stance that its emergency use authorization guidance, hung up at the White House, simply lays out stricter criteria for potential COVID-19 vaccines that industry has been aware of for months, despite suggestions from the White House that the guidance is a political ploy.

September 24, 2020 | Daily News

House Energy & Commerce Democratic leaders asked the HHS Inspector General to investigate possible political interference into the Centers for Disease Control and Prevention’s COVID-19 response following multiple reports of political appointees attempting to edit and delay scientific reports and conflicting messages from CDC and other parts of the administration.

September 18, 2020 | Daily News

HHS Secretary Alex Azar missed House Energy & Commerce Democratic leaders’ Friday (Sept. 18) deadline to brief them on his role in a slew of reported efforts by HHS political appointees to change scientific documents and communications coming out of the Centers for Disease Control and Prevention and on how he would prevent future political interference.

September 17, 2020 | Daily News

In a letter sent to FDA Thursday (Sept. 17), more than 90 organizations, led by the Infectious Diseases Society of America, urged agency officials to ensure the review process for any potential COVID-19 vaccine candidate will be transparent and adhere to high regulatory standards.

September 17, 2020 | Daily News

Newly published performance data for COVID-19 laboratory-developed tests show FDA’s desire to be more transparent with test developers and, according to a medical device industry lawyer, could persuade labs seeking to manufacture tests to pursue FDA authorization, even though they’re no longer required to have premarket or emergency authorization from the agency.

September 16, 2020 | Daily News

HHS’ top communications official, Michael Caputo, is taking a 60-day leave of absence following his reported efforts to alter scientific data coming out of the Centers for Disease Control and Prevention, and his senior policy advisor, Paul Alexander, who accused CDC of intentionally undermining the president, will leave the department, HHS announced Wednesday (Sept. 16).

September 14, 2020 | Daily News

House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and oversight subcommittee Chair Diana DeGette (D-CO) on Monday (Sept. 14) demanded HHS Secretary Alex Azar participate in an immediate briefing to respond to reports that appointees from the White House are working to review and change scientific COVID-19 public health reports and quiet public health officials.

September 11, 2020 | Daily News

Top FDA device center officials call for the United States to create a legislative framework for overseeing lab tests and to work with global partners to devise a plan for sharing clinical specimens to ensure diagnostic testing is accurate and reliable in future pandemics.

September 08, 2020 | Daily News

The Laboratory Corporation of American (LabCorp) introduced the first combined diagnostic test for COVID-19, influenza A/B and respiratory syncytial virus (RSV) on Tuesday (Sept. 8).

September 08, 2020 | Daily News

Former FDA chief Margaret Hamburg expressed confidence that FDA and other global regulators will follow the science when deciding whether to approve a COVID-19 vaccine, and she joined other current and former public health officials in calling for increased reliance on international regulators to make sure coronavirus vaccines are distributed equally around the globe.