Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
1/31/2025
/ Artificial Intelligence ,
Biden Administration ,
Data Management ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Transparency
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
12/11/2024
/ Artificial Intelligence ,
Biden Administration ,
Digital Health ,
Executive Orders ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Notice ,
Software