FDA Approvals News and Resources for Healthcare

EHR Costs Drain VA Budget, FDA Approval for ALS Treatment

October 4, 2022 - *This article has been updated to clarify the FDA's decision on Relyvrio* This week, the Department of Veterans Affairs (VA) continues to struggle with its EHR implementation as the Oracle-Cerner system draws funding from already thin budgets. Meanwhile, the FDA made a unique decision last Thursday, clarifying an earlier...

FDA Approves Remdesivir for Infants, Surprise Billing Battle Persists

May 11, 2022 by Hayden Schmidt

The FDA is promoting the use of an antiviral, Remdesivir, to treat COVID-19-infected infants after the drug was shown to be effective in a small clinical trial. Meanwhile, HHS asked a federal appeals...

Second Moderna Booster Gets FDA Approval, Biden Administration Eyes ACA Fix

April 06, 2022 by Hayden Schmidt

Moderna received FDA approval for its application to market a second round of boosters to adults 50 years and older. The fourth shot in the sequence has been shown to restore some of the immunity lost...

VA EHR Project Scrutinized in New Report, Cybersecurity in the $1.5T Budget Bill

March 23, 2022 by Hayden Schmidt

A recent report from the Office of the Investigator General detailed multiple issues that the VA experienced in a pilot test of its new EHR software. The report found critical problems with the...

FDA Approval for Eli Lilly Antibodies, HHS Issues $55M for Virtual Care

February 23, 2022 by Hayden Schmidt

The Department of Health and Human Services (HHS) is doling out $55 million to boost virtual care access at 29 community health centers. HHS secretary Xavier Beccara also announced that the agency had...

FDA’s New Emergency Authorizations, CMS Reinstates Vaccine Mandate

January 05, 2022 by Hayden Schmidt

CMS has issued a revised COVID-19 vaccine mandate for healthcare workers. The new mandate requires that healthcare workers in 25 states be vaccinated by the end of February 2022. In a series of...

Governors Codify Telehealth, CMS Funds 1,000 Medicare Residencies

December 29, 2021 by Hayden Schmidt

Newly discovered vulnerabilities in Apache’s Log4j software library are threatening healthcare systems that rely on the technology. HHS is addressing the issue with new guidance and warnings....

Bill Proposes Permanent Telehealth, Congress Sidesteps Medicare Cuts

December 15, 2021 by Hayden Schmidt

Legislation introduced by a group of bipartisan representatives intends to expand telehealth access to Medicare beneficiaries regardless of geography. Additionally, both chambers of Congress passed a...

Pfizer’s COVID-19 Vaccine Granted Full FDA Approval As CMS Ups Its Reimbursement

August 25, 2021 by Emily Sokol, MPH

COVID-19 remains in the spotlight of this week’s policy recap as Pfizer-BioNTech’s COVID-19 vaccine is granted full FDA approval. And CMS boosts reimbursement rates for COVID-19 vaccines...

Controversial Alzheimer’s Drug Under CMS, FDA Watch; EO Looks to Prescription Drug Spending

July 14, 2021 by Emily Sokol, MPH

CMS announced it will begin coverage determination investigations for the controversial Alzheimer’s drug, Aduhelm, while the drug’s approval process is also being investigated by the FDA....

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