5/15/2025 8:42:55 PM Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research By Vicki Tankle Sarah Thompson Schick Matthew Loughran On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health...
4/21/2023 2:40:21 PM New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development By Sarah Thompson Schick Rebecca Jones McKnight Vicki Tankle Roswill Mejia +1 more... Show less Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its...
5/20/2022 3:34:57 PM FDA issues draft guidance for use in product quality assessments By John Kendzior On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes...