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On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance")...
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software...
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights...
On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"...
Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However,...