Health Law Advisor

New from the Diagnosing Health Care Podcast: From removing diversity, equity, and inclusion initiatives to suspending foreign aid and canceling federal funding, it is clear that the current administration is drastically changing the landscape of government-funded research as we know it.

What should research institutions be doing now to best prepare themselves for what's to come? 

On this episode, Epstein Becker Green attorneys Marylana Saadeh Helou, Emily Chi Fogler, and Elizabeth McEvoy discuss how recent executive actions are impacting federally funded research at ambulatory medical centers, hospitals, universities, and other institutions, as well as how these actions may impact existing or future grants from the government.

Last week, the U.S. Department of Health and Human Services ("HHS") announced that FDA intends to update its regulations governing clinical studies of new drugs.  More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the "Code" or "CFR").  In its announcement, HHS stated that the revisions will be focused on defining and clarifying "the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements."  The ...