FDA Proposes Updated Framework for AI/ML Medical Device Regulation
The U.S. Food and Drug Administration released draft guidance in 2023 that outlines recommendations for manufacturers…
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Legislation, oversight, and evergreen explainers grounded in primary documents.
What to Know About Current COVID-19 Booster Guidance and Vaccine Effectiveness
The U.S. Centers for Disease Control and Prevention advises that everyone 6 months and older receive the updated…
Read More →FDA Clarifies Enrollment Standards for Geriatric Patients in Drug Development
The Food and Drug Administration adopted guidance that pushes drug developers to include older adults in clinical…
Read More →FDA Updates Rules for Structure-Function Claims on Dietary Supplements
The U.S. Food and Drug Administration issued updated guidance that spells out expectations for structure-function…
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