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
The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more
When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...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
Last week, the US Department of Health and Human Services (HHS) announced that it will undergo a major restructuring and plans to eliminate 10,000 employees on top of 10,000 HHS employees who have already departed (20,000...more
On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government...more
On January 27th, the Trump administration issued an order (the January 27th order) freezing all federal grants and loans, which would have cut billions of dollars of federal funding, largely to research universities....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
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more
SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more
In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...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
Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more