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 September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
Liability exposure and shields for vaccine developers - As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more