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FDA Clarifies Labeling Expectations For Prescription Drug Use-Related Software - Healthcare

On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance")...
Drug Administration Radiological Health Software Functions Software The Guidance Software Function Regulatory Considerations
Source: mondaq.com

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software | Sheppard Mullin Richter & Hampton LLP

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software...
Software Function Radiological Health Sheppard Mullin Richter Hampton Software The Guidance Software Functions Device Software Functions

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International Truck Launches Cummins X15 Over-The-Air Engine Calibrations

Share this article Share this article LISLE, Ill., May 20, 2021 /PRNewswire/ -- International Truck, the commercial truck brand of Navistar International Corporation (NYSE: NAV), today announced the upcoming availability of Cummins ® Connected Software Updates ® Connection portal, enabled by Navistars factory installed second-generation telematics device. The two digital applications from Cummins, together with OnCommand Connection, will allow customers the capability to conduct over-the-air...
Krista Toenjes Brian Mulshine Navistar Oncommand Navistar International Corporation Lone Star International Truck

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