The Regulatory Environment for the Artificial Pancreas

Host: Timothy Bailey, MD Guest: Aaron Kowalski, PhD 12.00 72 1024x768 Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;} The artificial pancreas project lead by the Juvenile Diabetes Research Foundation has made tremendous progress towards eventual outpatient clinical studies. A recent panel of experts met with the FDA and NIH to determine appropriate guidelines. What are regulatory guidelines for the artificial pancreas project? Join guest host Dr. Timothy Bailey and his guest, Assistant Vice President and Director of Glucose Control Research at the Juvenile Diabetes Research Foundation, Dr. Aaron Kowalski as they discuss developments from controlled inpatient settings to real-world conditions and the need for regulation.