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FDA Issues New Framework for Real-World Evidence on Digital Mental Health Tools
The U.S. Food and Drug Administration has released updated guidance that allows sponsors to submit real-world data and…
Read More →FDA Modernizes Framework for Software-Based Mental Health Treatments
The U.S. Food and Drug Administration released draft guidance in September 2023 that updates how software products…
Read More →New Insights from NIH and WHO Data on Long COVID Duration and Therapeutic Trials
World Health Organization guidance and cohort studies describe Long COVID as symptoms that continue for at least two…
Read More →FDA Outlines Regulatory Expectations for Digital Tools Targeting Behavioral Health and Mindfulness
The FDA applies its existing policies to software that claims effects on behavioral health or mindfulness. Tools…
Read More →FDA Clarifies Oversight for Digital Tools Used in Stress Management and Mindful Movement
FDA Policy Distinguishes Regulated Devices From Low-Risk Wellness Tools for Stress and Activity
Read More →How to Rethink Your Weight Management Program
Move beyond restrictive diets and scale obsession to build a sustainable, compassionate, and personalized approach…
Read More →FDA Outlines When Digital Tools for Stress Management and Mindful Movement Qualify as Medical Devices
FDA Draft Guidance Clarifies When Digital Health Technologies for Stress and Physical Activity Qualify as Medical…
Read More →What Multiple Systematic Reviews from Cochrane and PubMed Show About Tai Chi, Yoga, and MBSR in Adults over 60
How Effective Are Mindful Movement Interventions Like Yoga, Tai Chi, and Qigong for Stress Reduction in Older Adults?
Read More →Key Findings from Cochrane Reviews and NIH Sources on Tai Chi, Yoga and Stress in Aging Populations
National Center for Complementary and Integrative Health summaries review dozens of randomized trials on yoga, tai chi…
Read More →Which Men's Self Care Product Is Best
Guide to which mens self care product is best
Read More →FDA Clarifies Evidence Standards for Digital Tools Marketed to Support Stress Management and Mindful Movement
FDA Draft Guidance Clarifies Oversight of Digital Therapeutics for Stress and Anxiety
Read More →FDA Outlines Regulatory Pathways for Prescription Digital Tools in Stress Management
The FDA evaluates certain digital tools for stress management as medical devices when they make claims about treating…
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