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

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

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S. Emphasis in original.)

COVID-19

COVID-19 Public Health FDA Hospitals

Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids

Healthcare Dive

FEBRUARY 2, 2022

The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5.

COVID-19 Vaccine

COVID-19 Vaccine FDA COVID-19

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

Aetion, FDA to Evaluate Real-World Data Standardization for COVID-19

HIT Consultant

DECEMBER 7, 2022

What You Should Know: – Aetion , a provider of real-world evidence (RWE) technology and analytics, today announced that the FDA has extended Aetion’s contract to evaluate real-world data (RWD) involving COVID-19 medical countermeasures.

COVID-19

COVID-19 FDA

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

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

First COVID-19 Breathalyzer Test Authorized By FDA

The Health Law Firm Blog

JULY 20, 2023

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S.

COVID-19

COVID-19 FDA Doctors Health Insurance

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

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 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

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

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

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

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 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

COVID-19 Tests With Inaccurate Results

American Medical Compliance

AUGUST 18, 2022

Many people use rapid at home COVID-19 tests to ensure that they have not contracted the virus. Receiving one negative test result does n0t necessarily mean that someone doesn’t have COVID-19. Repeat COVID-19 Tests. However, a PCR COVID-19 test has a higher detection rate of 95%.

COVID-19

COVID-19 COVID-19 Vaccine FDA Compliance

FDA approves another COVID-19 booster dose for older adults

Modern Healthcare

APRIL 18, 2023

The COVID-19 booster dose was cleared Tuesday and is for older adults and people with weak immune systems.

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

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

FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

Healthcare Dive

FEBRUARY 14, 2022

The agency pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 FDA

First COVID-19 Breathalyzer Test Authorized By FDA

The Health Law Firm Blog

APRIL 24, 2022

Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On April 14, 2022, the U.S.

COVID-19

COVID-19 FDA Doctors Health Insurance

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

CDC backs updated COVID-19 shots from Pfizer, Moderna

Healthcare Dive

SEPTEMBER 2, 2022

One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.

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

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

COVID-19 Booster Updates

American Medical Compliance

AUGUST 12, 2022

Cases of COVID-19 are still occurring across the United States due to more contagious Omnicron variants. Current COVID-19 boosters are safe and effective. Furthermore, the FDA is encouraging COVID-19 vaccine manufacturers to update their booster shots to protect against BA.4 Second COVID-19 Booster.

COVID-19

COVID-19 COVID-19 Vaccine Compliance 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

FDA Guidance for Face Masks During Covid-19 Pandemic

Exeed Regulatory Compliance

JULY 6, 2020

There is a lot of controversy over the use of face masks during the current Covid-19 pandemic. Let us understand how they help and how FDA plans to regulate them. Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE).

COVID-19

COVID-19 FDA Medical Device Industry Public Health

FDA's authorization process compromised COVID-19 tests in 2020

Modern Healthcare

SEPTEMBER 22, 2022

An analysis of the FDA's emergency use authorization process underscores the need for a national testing strategy, HHS inspectors said.

FDA

FDA COVID-19

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

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

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

Exeed Regulatory Compliance

AUGUST 3, 2020

Now there is a test for diagnosing COVID-19 in asymptomatic individuals. One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. CONTACT US.

COVID-19

COVID-19 FDA

FDA advisers back Novavax COVID-19 shots as new U.S. option

Modern Healthcare

JUNE 7, 2022

FDA's vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves.

FDA

FDA COVID-19

AI-Enabled Butterfly Network Lung Tool Receives FDA Clearance

HIT Consultant

APRIL 3, 2023

What You Should Know: – Today, Butterfly Network announced it received 510(k) clearance from the FDA for a groundbreaking AI-enabled tool named AI-enabled Auto B-line Counter that will help physicians assess adults’ lungs and accelerate providers’ abilities to make informed treatment decisions.

FDA

FDA COVID-19

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

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

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

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

Exeed Regulatory Compliance

JULY 10, 2020

The FDA’s updated policies are striving to make sure PPE is both available and regulated for safe use. The medical landscape is constantly changing, particularly during the COVID-19 pandemic. We recently discussed the FDA’s policy for Face Masks during COVID-19.

COVID-19

COVID-19 FDA Medical Device Industry Public Health

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

COVID-19 Update: New Variants and Vaccine Research

Health Law Pulse

FEBRUARY 11, 2022

Although receiving the COVID-19 vaccine remains one of the best ways to combat the severity of one’s symptoms, Dr. Van Kerkhove warned that the vaccine could become less effective as the virus continues to evolve. The post COVID-19 Update: New Variants and Vaccine Research appeared first on Health Law Pulse.

COVID-19

COVID-19 COVID-19 Vaccine FDA Public Health

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

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

Trending Sources

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

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

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids

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

Aetion, FDA to Evaluate Real-World Data Standardization for COVID-19

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

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

First COVID-19 Breathalyzer Test Authorized By FDA

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

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

FDA clears updated COVID-19 boosters from Pfizer, Moderna

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

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

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

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

FDA takes N95 respirators off medical device shortage list

COVID-19 Tests With Inaccurate Results

FDA approves another COVID-19 booster dose for older adults

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

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

FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

First COVID-19 Breathalyzer Test Authorized By FDA

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

CDC backs updated COVID-19 shots from Pfizer, Moderna

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

FDA advisers grapple with how to update COVID-19 vaccines

COVID-19 Booster Updates

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

FDA Guidance for Face Masks During Covid-19 Pandemic

FDA's authorization process compromised COVID-19 tests in 2020

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

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

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

FDA advisers back Novavax COVID-19 shots as new U.S. option

AI-Enabled Butterfly Network Lung Tool Receives FDA Clearance

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

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

Cue Health wins first non-emergency authorization for COVID test

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

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

COVID-19 Update: New Variants and Vaccine Research

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