With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
4/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
New Legislation ,
Prescription Drugs ,
Regulatory Reform ,
Tariffs
A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more
Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more
The American Telemedicine Association (ATA) brought key telehealth stakeholders and policymakers together for the annual ATA EDGE policy conference on December 13-15, 2023, in Washington, D.C. Since 2020, patients and...more
The annual Medicare physician payment rule is upon us, proposed July 13, 2023, for calendar year (CY) 2024 and open for public comment through September 11. Each year, the couple-of-thousand-page rule makes modifications to...more
On May 9th, 2023, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) extended the telemedicine flexibilities that allowed the remote prescribing of controlled...more
In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more
A study by the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services and the National Institute on Drug Abuse suggests that telehealth expansions instated during the COVID-19 public health...more
Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more
Two prominent vaccine manufacturers submitted requests for authorization of an additional COVID-19 booster dose this week. Meanwhile, as case rates rise in Europe and China, U.S. public health officials take stock of what to...more
As many mask mandates are lifted, the federal government extended its travel mask mandate by one month, and a new study illustrates the value in judicious mask use.
Florida’s New Pediatric Vaccine Guidance...more
New guidance and pandemic preparedness strategies from the federal government highlight this week’s COVID-19 news.
Biden Administration New Measures To Combat COVID-19...more
As vaccination rates drop to an all-time low in the United States, the CDC is preparing new guidance on measuring the severity of outbreaks in our communities. Meanwhile, a study on the impact of hospitalization on the mental...more
In this edition of the COVID-19 weekly newsletter, we take a look at a number of international COVID-19 news items.
U.S. Doses Turned Away Due to Logistical Hurdles -
The U.S. has donated and shipped 437 million doses...more
As the number of cases throughout the nation drops, states are starting to lift mask mandates and COVID-19 restrictions. However, some leaders have cautioned against easing practices that mitigate spread. Meanwhile, recent...more
A number of recent studies have sought to identify commonalities among COVID-19 patients under the age of 18 who have required hospitalization. In addition, many new studies have worked to measure the impact of the COVID-19...more
This week, early findings of an NIH-backed study were released — showing that a combination of doses from any authorized vaccines is safe and effective. Meanwhile, the Department of Labor shifts focus to a traditional...more
This week, the Biden administration formed a new task force to plan for future variants and made COVID-19 tests available for free through the mail, while medical leaders continue to sound the alarm about increasingly dire...more
The Biden administration signaled new plans to make tests and masks available for free, in the same week that the Supreme Court blocked the federal government from enforcing its “vaccine or test” mandate for private...more
As 2022 gets underway, public health agencies have been busy updating guidelines and working to expand vaccine access as health care providers and researchers contend with the now-dominant Omicron variant.
‘Flurona’ Case...more
In our final newsletter of 2021, we share updates on the federal government’s latest vaccine recommendations, the spread of the Omicron variant, and what the preliminary findings tell us about the need for booster shots to...more
As the holiday season continues, the Omicron variant has prompted an exceptional level of research activity and information-sharing. The early evidence on the Omicron variant is a mixture of encouraging news and more...more
The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of...more
Major developments in vaccine authorizations and mandates continue in the U.S., while the surge in Europe has prompted one country to implement a lockdown — and also declare a national vaccine mandate.
mRNA COVID-19...more
A global vaccine tracker is unveiled as cases are on the rise for the first time in two months. With herd immunity unlikely at this point, researchers are developing the next generation of COVID-19 vaccines.
COVID Cases...more