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
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
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
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
Earlier today, the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released preliminary guidelines on the allocation of initial and limited supplies of a forthcoming COVID-19 vaccine. Once finalized,...more