COVID-19 and FDA - Health Care Compliance Brief

'Appropriate' transition period for COVID-19 test EUAs when public health emergency ends

Healthcare Dive

APRIL 8, 2022

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

COVID-19

COVID-19 Public Health FDA

FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Healthcare Dive

JUNE 15, 2022

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

COVID-19 Vaccine

COVID-19 Vaccine FDA COVID-19

FDA warns about unauthorized versions of rapid COVID-19 tests from 3 manufacturers

Healthcare Dive

MARCH 3, 2022

But the FDA has learned some unauthorized versions of their diagnostics have entered the country. The manufacturers have all received emergency use authorizations for antigen tests.

FDA

FDA COVID-19

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Bridging Innovation & Patient Care: The Growing Role of AI

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Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

Healthcare Dive

SEPTEMBER 22, 2022

The HHS Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

COVID-19

COVID-19 FDA

FDA clears Novavax's COVID-19 vaccine as 4th option in US

Healthcare Dive

JULY 13, 2022

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

FDA takes N95 respirators off medical device shortage list

Healthcare Dive

AUGUST 30, 2022

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

COVID-19

COVID-19 FDA Public Health

First OTC, app-connected COVID-19 test authorized by FDA

Mobi Health News

DECEMBER 15, 2020

Alongside step-by-step instructions, the Ellume COVID-19 Home Test's accompanying app automatically reports users' results to the relevant public health authorities.

COVID-19

COVID-19 FDA Public Health

FDA grappling with influx of illegal COVID-19 tests entering US

Healthcare Dive

MARCH 23, 2022

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

COVID-19

COVID-19 FDA

FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments

HIT Consultant

OCTOBER 21, 2021

Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. Enables rapid evidence generation for COVID-19 and future pandemics.

COVID-19

COVID-19 FDA Public Health

US turns to Gilead's COVID-19 drug to help counter omicron

Healthcare Dive

JANUARY 25, 2022

With other COVID-19 treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.

COVID-19

COVID-19 FDA

FDA streamlines pathway to at-home asymptomatic COVID-19 test approval

Mobi Health News

MARCH 18, 2021

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.

COVID-19

COVID-19 FDA Public Health

Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

OCTOBER 31, 2022

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. However, the act of submitting an application to the FDA based on such research (e.g.,

COVID-19

COVID-19 COVID-19 Vaccine Licensing FDA

FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

Healthcare Dive

APRIL 7, 2022

The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 2 is now dominant in the U.S.,

COVID-19

COVID-19 FDA

FDA contracts Aetion’s real-world evidence platform to assess COVID-19 treatments

Fierce Healthcare

OCTOBER 20, 2021

FDA contracts Aetion’s real-world evidence platform to assess COVID-19 treatments. Wed, 10/20/2021 - 16:59.

COVID-19

COVID-19 FDA

Paxlovid Paradox, Part 1: Trying to Outrun COVID-19

Healthcare IT Today

MAY 25, 2022

With COVID-19 infections and hospitalizations rising, the FDA approved two drugs—Paxlovid from Pfizer, and molnupiravir from Merck and Ridgeback—to treat the illness that is killing so many and rendering others permanently disabled. The dilemma is heart-rending.

COVID-19

COVID-19 FDA Hospitals Telemedicine

FDA clears updated COVID-19 boosters from Pfizer, Moderna

Healthcare Dive

AUGUST 31, 2022

The new shots, which are designed to better target circulating strains of omicron, could be available within days. Advisers to the CDC are set to meet later this week.

COVID-19

COVID-19 FDA

Lucira Health files for bankruptcy as it receives EUA for home COVID-19, flu test

Mobi Health News

FEBRUARY 27, 2023

Lucira's diagnostic is the first over-the-counter at-home combination test for COVID-19 and flu authorized by the FDA.

COVID-19

COVID-19 FDA

HIMSSCast: Predicting what's next for health IT, mobile tech and health system finances

Healthcare It News

DECEMBER 16, 2022

FDA and evolving regulations for digital therapeutics, software as a medical device. Up to 18 million people could lose Medicaid coverage after COVID-19 PHE. Automation, and how it can help clinician burnout and back-office processes. Cybersecurity and the patient safety risks of ransomware.

COVID-19

COVID-19 Public Health Ransomware FDA

HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program

Mobi Health News

MARCH 30, 2020

The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.

COVID-19

COVID-19 FDA

The latest on COVID-19 testing: FDA updates; Ready Responders land $48M to administer COVID-19 tests at home

Mobi Health News

APRIL 1, 2020

Also Cue Health scores $13 million from the department of Health and Human Services Biomedical Advanced Research and Development authority in order to fund its portable COVID-19 diagnostic test.

COVID-19

COVID-19 FDA

FDA warns Ellume's at-home COVID-19 test may give false positive results

Mobi Health News

OCTOBER 5, 2021

The FDA said negative test results don’t appear to be affected.

FDA

FDA COVID-19

Amazon lands EUA for COVID-19 test with home sample collection

Mobi Health News

MARCH 29, 2021

According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees. .

COVID-19

COVID-19 FDA Public Health

FDA approves Roche's Actemra for treating severe cases of COVID-19

Fierce Healthcare

DECEMBER 22, 2022

FDA approves Roche's Actemra for treating severe cases of COVID-19. Thu, 12/22/2022 - 08:40.

COVID-19

COVID-19 FDA

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

JULY 1, 2022

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. The global impact of COVID-19 on drug purchases: A cross-sectional time series analysis. A full posting of abstracts/summaries of these articles may be found on our? 2022 May 3.

COVID-19

COVID-19 FDA Medicare Medicare

Cue Health Launches DTC Virtual Health Platform Featuring COVID-19 Self Test

HIT Consultant

NOVEMBER 11, 2021

What You Should Know: – Cue Health (Nasdaq: HLTH), a healthcare technology company, launches its direct-to-consumer (DTC) virtual health platform, making its first-of-its-kind molecular COVID-19 test available to people across the United States. FDA-Authorized COVID-19 Test. – Cue+ Complete™($89.99/month):

COVID-19

COVID-19 FDA Doctors

Amazon in talks to launch at-home medical testing service, says Insider

Healthcare IT News - Telehealth

MAY 18, 2021

According to reporting from Insider , Amazon is considering launching an at-home COVID-19-testing kit in June, and potentially ones for respiratory and sexually transmitted infections. It also gained Food and Drug Administration authorization for its at-home COVID-19 tests in March. ON THE RECORD.

COVID-19

COVID-19 FDA

Lucira Health Secures $80M to Expand COVID-19 Test Kit

HIT Consultant

FEBRUARY 8, 2022

. – Lucira’s COVID-19 testing platform produces lab-quality molecular testing in a single-use, consumer-friendly, palm-size test kit powered by two AA batteries.

COVID-19

COVID-19 FDA

FDA authorizes first COVID-19 test for self-testing at home

Mobi Health News

NOVEMBER 18, 2020

Lucira's molecular testing kit allows individuals to collect their own nasal sample and insert it into a device that provides results in under 30 minutes. The company is aiming to sell the single-use tests for roughly $50.

COVID-19

COVID-19 FDA

FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

Healthcare Dive

JUNE 17, 2022

The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use. A CDC panel is meeting Friday and Saturday to develop specific recommendations.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

FDA advisers grapple with how to update COVID-19 vaccines

Healthcare Dive

APRIL 7, 2022

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

Jasper Health Integrates BioIntelliSense’s RPM and COVID-19 Screening Solution for Members

HIT Consultant

AUGUST 26, 2021

. – As part of the strategic collaboration, Jasper Health will integrate the BioIntelliSense FDA-cleared BioSticker and medical grade BioButton® wearable devices as part of its remote member engagement and guidance platform.

COVID-19

COVID-19 FDA

CareCloud CEO predicts what's around the corner for telehealth

Healthcare It News

DECEMBER 1, 2021

By now, it's become a truism that telehealth use saw an enormous jump in 2020 , spurred by the COVID-19 pandemic and enabled by the relaxation of federal regulations. What are some of your predictions for 2022 and beyond about the way telehealth will be used, especially as the COVID 19 pandemic continues?

COVID-19

COVID-19 Public Health Doctors Governance

BioIQ releases at-home COVID-19 and flu saliva sample collection kit

Mobi Health News

JUNE 16, 2020

This morning BioIQ, a health-testing and biometric-screening technology company, released its at-home COVID-19, Flu A/Flu B, and 21 Test Respiratory Panel saliva test. The company partnered with P23 labs, which already scored an emergency use authorization (EUA) from the FDA for its at-home saliva COVID-19 test kits.

COVID-19

COVID-19 FDA

Moderna seeks FDA clearance for COVID-19 vaccine in young children

Healthcare Dive

APRIL 28, 2022

The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

U.S. inks $232 million deal with Ellume for at-home rapid COVID-19 tests

Mobi Health News

FEBRUARY 2, 2021

The Ellume COVID-19 Home Test was the first rapid self-test authorized by the FDA for the detection of COVID-19 in individuals with or without symptoms.

COVID-19

COVID-19 FDA

Congress gives $10M to DoD, Philips to advance AI-driven disease prediction

Healthcare It News

APRIL 27, 2023

With data from more 11,000 individuals monitored during the COVID pandemic, DoD can issue commercial wearables "to noninvasively monitor a service member’s health and provide early alerts to potential infection before it spreads," said Jeff Schneider, program manager for the RATE, in a statement.

COVID-19

COVID-19 FDA Licensing Hospitals

Spread of coronavirus from lab unlikely, WHO says; FDA clears Amazon COVID-19 test kit

Healthcare IT News - Telehealth

APRIL 2, 2021

Enterprise Taxonomy: Short Headline: Spread of coronavirus from lab unlikely, WHO says; FDA clears Amazon COVID-19 test kit Featured Decision Content: Region Tag: Global Edition Right Now: Primary topic: Population Health.

COVID-19

COVID-19 FDA

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

Mobi Health News

MARCH 5, 2021

The system delivers its results to a companion app in about 20 minutes, according to the agency.

COVID-19

COVID-19 FDA Public Health

At-home COVID-19 testing services pump the brakes after FDA warns of 'fraudulent' kits

Mobi Health News

MARCH 23, 2020

Nurx and Carbon Health have officially halted their mail-order testing kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.

COVID-19

COVID-19 FDA

Cue Health wins first non-emergency authorization for COVID test

Healthcare Dive

JUNE 8, 2023

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

COVID-19

COVID-19 FDA

CDS algorithm that predicts COVID-19 complications receives Emergency Use Authorization from FDA

Mobi Health News

OCTOBER 6, 2020

Dascena's COViage system uses demographic and vital-sign data pulled from a COVID-19 patients' EHR to calculate their risk of hemodynamic instability or respiratory failure.

COVID-19

COVID-19 FDA

With new EUA, LabCorp's COVID-19 diagnostic now handles asymptomatic, pooled testing

Mobi Health News

JULY 27, 2020

The FDA now allows LabCorp's platform to test patients with no COVID-19 symptoms, or to run samples from up to five patients at a time.

COVID-19

COVID-19 FDA

US health officials propose annual COVID-19 vaccination for most Americans

Modern Healthcare

JANUARY 23, 2023

The FDA's simplified approach aims to make COVID-19 vaccinations more like the annual flu shot.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

Detect scores EUA from FDA for at-home molecular COVID-19 test

Mobi Health News

OCTOBER 29, 2021

Detect uses an app to help users perform the test and interpret the results.

COVID-19

COVID-19 FDA

'Appropriate' transition period for COVID-19 test EUAs when public health emergency ends

FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Webinars

Trending Sources

FDA warns about unauthorized versions of rapid COVID-19 tests from 3 manufacturers

Webinars

Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

FDA clears Novavax's COVID-19 vaccine as 4th option in US

FDA takes N95 respirators off medical device shortage list

First OTC, app-connected COVID-19 test authorized by FDA

FDA grappling with influx of illegal COVID-19 tests entering US

FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments

US turns to Gilead's COVID-19 drug to help counter omicron

FDA streamlines pathway to at-home asymptomatic COVID-19 test approval

Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

FDA contracts Aetion’s real-world evidence platform to assess COVID-19 treatments

Paxlovid Paradox, Part 1: Trying to Outrun COVID-19

FDA clears updated COVID-19 boosters from Pfizer, Moderna

Lucira Health files for bankruptcy as it receives EUA for home COVID-19, flu test

HIMSSCast: Predicting what's next for health IT, mobile tech and health system finances

HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program

The latest on COVID-19 testing: FDA updates; Ready Responders land $48M to administer COVID-19 tests at home

FDA warns Ellume's at-home COVID-19 test may give false positive results

Amazon lands EUA for COVID-19 test with home sample collection

FDA approves Roche's Actemra for treating severe cases of COVID-19

Monthly Round-Up of What to Read on Pharma Law and Policy

Cue Health Launches DTC Virtual Health Platform Featuring COVID-19 Self Test

Amazon in talks to launch at-home medical testing service, says Insider

Lucira Health Secures $80M to Expand COVID-19 Test Kit

FDA authorizes first COVID-19 test for self-testing at home

FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

FDA advisers grapple with how to update COVID-19 vaccines

Jasper Health Integrates BioIntelliSense’s RPM and COVID-19 Screening Solution for Members

CareCloud CEO predicts what's around the corner for telehealth

BioIQ releases at-home COVID-19 and flu saliva sample collection kit

Moderna seeks FDA clearance for COVID-19 vaccine in young children

U.S. inks $232 million deal with Ellume for at-home rapid COVID-19 tests

Congress gives $10M to DoD, Philips to advance AI-driven disease prediction

Spread of coronavirus from lab unlikely, WHO says; FDA clears Amazon COVID-19 test kit

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

At-home COVID-19 testing services pump the brakes after FDA warns of 'fraudulent' kits

Cue Health wins first non-emergency authorization for COVID test

CDS algorithm that predicts COVID-19 complications receives Emergency Use Authorization from FDA

With new EUA, LabCorp's COVID-19 diagnostic now handles asymptomatic, pooled testing

US health officials propose annual COVID-19 vaccination for most Americans

Detect scores EUA from FDA for at-home molecular COVID-19 test

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