9/3/2024 7:52:42 PM Artificial Intelligence raises important legal and policy considerations for patient data and clinical trials By Matthew Loughran The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create...
6/9/2023 9:24:19 PM FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts By Kevin Madagan Sarah Thompson Schick Note: This is Part 2 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its...
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...
3/24/2022 7:22:38 PM OIG approves arrangement encouraging device study enrollment for economically disadvantaged Medicare beneficiaries By Andrew Sylora In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical...
9/16/2020 4:28:08 PM FDA issues draft guidance regarding principles for selecting, developing, modifying, & adapting patient-reported outcome instruments for use in medical device evaluation By John Kendzior Ryan Pate On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...
6/19/2020 5:28:54 PM FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency By John Kendzior Ryan Pate On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by...