Has this ever happened to you? Misplacing your reading glasses, almost daily? Forgetting names, even of good friends and colleagues? Puzzling over why you just walked into the kitchen? Spending a big part of each day...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more
In response to President Trump’s February 13, 2025, Executive Order (EO) 14212, “Establishing The President’s Make America Healthy Again Commission,” the White House issued part of what is being called “The MAHA Report” (with...more
On May 22, 2025, President Trump’s Make America Healthy Again (MAHA) Commission released an assessment titled “The MAHA Report: Make Our Children Healthy Again Assessment.” The report—framed as a “call to action”—stems from a...more
Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more
Public Health - Withdrawing from the World Health Organization (WHO)...more
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more
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
On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of Health and Human Services and the White House shortly thereafter issued an Executive Order establishing the Make America Healthy...more
On Feb. 13, moments after Robert F. Kennedy Jr. was confirmed as secretary of health and human services, President Donald Trump issued his first health care Executive Order (EO) under new leadership, laying the groundwork to...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: ·Republican AGs Have Beef with Nutritional Standards Report...more
RFK Jr. Confirmed as HHS Secretary. In a 52 – 48 Senate vote, Robert F. Kennedy (RFK) Jr. was confirmed as the next HHS secretary. All Democrats voted no, and Sen. McConnell (R-KY) was the only Republican to join them. He...more
A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more
A Massachusetts federal judge has issued a temporary restraining order preventing the implementation and enforcement of the National Institutes of Health's (NIH) research funding cut (NOT-OD-25-086) (the Rate Change Notice)....more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more
President-Elect Donald Trump is poised to expand upon policies he implemented during his first term in office, such as those emphasizing limited government, states' rights and lower taxes. Additionally, it is anticipated that...more
The U.S. Food and Drug Administration (FDA) has revoked its regulation authorizing the use of brominated vegetable oil as a food ingredient used to stabilize flavoring oils in fruit-flavored beverages after concluding it is...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more