The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,” which proposes updates to the...more
The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more
On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, “Diversity Plans to Improve Enrollment of...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more