FDA Approves Arexvy and Abrysvo: Primary Regulatory Details on RSV Prevention in Adults 60+
The FDA approved Arexvy on May 3, 2023 as the first vaccine to prevent lower respiratory tract disease caused by RSV…
Read More →FDA & Regulation
Federal drug and device approvals, safety alerts, and regulatory guidance.
FDA Outlines Regulatory Expectations for AI-Driven Digital Tools Claiming to Assess Heart Disease Risk in Men
FDA Clarifies Expectations for Software Tools Assessing Cardiovascular Risk
Read More →FDA Warns of Adverse Events Linked to Unapproved Compounded Versions of GLP-1 Drugs
The Food and Drug Administration has updated its safety communications regarding compounded semaglutide. Officials…
Read More →FDA Clarifies Which Digital Wellness Tools Fall Under Medical Device Regulation
The FDA has spelled out more details on its oversight of digital health products. Its risk-based framework looks at…
Read More →FDA Clears Zepbound as New Option for Obesity Treatment
FDA Approves Zepbound (Tirzepatide) for Chronic Weight Management
Read More →FDA Clears First OTC CGM Device for Diabetes Management and Prevention
FDA Clears First Over-the-Counter Continuous Glucose Monitor
Read More →FDA Outlines Predetermined Change Control Plans for AI/ML-Based Cardiac Devices
FDA Updates Regulatory Expectations for AI-Enabled Cardiovascular Monitoring Devices
Read More →FDA Outlines New Regulatory Expectations for AI-Driven Cardiac Diagnostics and Remote Monitoring Tools
FDA Clarifies Path for Updates to AI Software Used in Heart Monitoring Devices
Read More →FDA Outlines Regulatory Expectations for AI-Driven Heart Monitoring Wearables
FDA Draft Guidance Outlines Expectations for AI Wearables in Cardiovascular Risk Assessment
Read More →FDA Identifies Undeclared PDE5 Inhibitors in Over-the-Counter Products Marketed for Sexual Enhancement
FDA Documents Hidden PDE-5 Inhibitors in Dozens of Male Enhancement Supplements
Read More →CDC Issues Updated RSV Vaccine Guidance for Adults 60 and Older
ACIP Updates RSV Vaccine Recommendations for Older Adults
Read More →FDA Outlines Regulatory Expectations for AI/ML-Based Digital Wellness Tools
The Food and Drug Administration has issued draft guidance that applies its existing rules to AI-powered software…
Read More →FDA Authorizes Updated mRNA COVID-19 Vaccines Targeting KP.2 Variant for 2024-2025 Season
FDA Authorizes Updated Monovalent COVID-19 Vaccines Targeting KP.2 for 2024-2025 Season
Read More →FDA and CDC Clear Reformulated mRNA COVID-19 Vaccines for Fall 2024 Use
FDA Authorizes Updated 2024-2025 COVID-19 Vaccines Targeting KP.2 Lineage
Read More →USPSTF Updates Statin Guidance for Adults Ages 40–75 at Risk of Cardiovascular Disease
The U.S. Preventive Services Task Force updated its recommendation on statin use for primary prevention of…
Read More →FDA Detects Hidden PDE5 Inhibitors in OTC Male Enhancement Products
FDA Issues Safety Communication on Tainted Male Sexual Enhancement Supplements
Read More →CDC Issues Shared Clinical Decision-Making Guidance for RSV Vaccines Targeting Older Adults
CDC Issues Updated Recommendations for RSV Vaccination in Adults Aged 60 and Older
Read More →FDA Clarifies When Wellness Apps and Wearables Fall Under Medical Device Regulation
The FDA applies a risk-based approach to digital health technologies. It generally exercises enforcement discretion…
Read More →FDA Outlines Predetermined Change Control Plans for AI Tools in Digital Health
FDA Draft Guidance Clarifies When AI Wellness Software Avoids Medical Device Rules
Read More →FDA Warns Consumers About Hidden PDE5 Inhibitors in Over-the-Counter Male Enhancement Products
The U.S. Food and Drug Administration has identified multiple male sexual enhancement supplements that contain…
Read More →FDA Outlines Predetermined Change Control Plans for AI-Enabled Medical Devices
FDA Guidance Details Plans for Updates to AI Software Used in Medical Devices
Read More →FDA Clarifies Regulatory Expectations for AI Tools in Heart Disease Prevention
FDA Issues Draft Guidance on AI/ML Software for Cardiovascular Risk Assessment
Read More →FDA Clarifies Regulatory Expectations for Software Monitoring Cardiovascular and Metabolic Parameters in Men
FDA Clarifies Regulatory Expectations for Digital Health Technologies in Remote Physiologic Monitoring
Read More →FDA Authorizes Reformulated mRNA COVID-19 Vaccines for 2024-2025 Season
FDA Authorizes Updated 2024-2025 COVID-19 Vaccines Targeting KP.2 Variant
Read More →FDA Clarifies Oversight of Software and Devices Marketed for Digital Wellness Tracking
FDA Guidance Excludes Low-Risk Wellness Technologies From Medical Device Regulation
Read More →FDA Clears Dexcom Stelo as First OTC CGM for Adults 18 and Older Not Using Insulin
FDA Clears First Over-the-Counter Continuous Glucose Monitor
Read More →CDC Issues Shared Clinical Decision-Making Guidance for RSV Vaccines in Older Adults
CDC Updates RSV Vaccine Recommendations for Adults Aged 60 and Older
Read More →CDC Issues Risk-Based Guidance on RSV Vaccines for Adults 60 and Older
The CDC updated its guidance on RSV vaccination for older adults. The agency moved from a shared clinical decision…
Read More →FDA Warns of Hidden Ingredients in Online Erectile Dysfunction Products
FDA Updates Tracking of Tainted Sexual Enhancement Products Containing Undeclared PDE5 Inhibitors
Read More →FDA Warns of Hidden PDE5 Inhibitors and Anabolic Steroids in Over-the-Counter Male Supplements
FDA Warns of Hidden PDE5 Inhibitors and Anabolic Steroids in Over-the-Counter Male Supplements
Read More →FDA Warns of Dosing Errors and Adverse Events Linked to Compounded Semaglutide
FDA Alerts Providers to Adverse Events and Dosing Errors Associated With Compounded Semaglutide
Read More →FDA Clarifies Regulatory Expectations for AI-Driven Digital Wellness Interventions
FDA Clarifies Regulatory Expectations for AI-Driven Digital Wellness Interventions
Read More →FDA Warns of Undeclared PDE5 Inhibitors in OTC Male Enhancement Products
FDA Warns of Undeclared PDE5 Inhibitors in OTC Male Enhancement Products
Read More →FDA Revises Labeling and Monitoring Guidance for GLP-1 Drugs Used in Type 2 Diabetes and Weight Management
FDA Updates Postmarket Safety Monitoring Requirements for GLP-1 Receptor Agonists
Read More →FDA Outlines Regulatory Framework for AI Tools Used in Preventive Cardiac Monitoring
FDA Outlines Regulatory Framework for AI Tools Used in Preventive Cardiac Monitoring
Read More →FDA Mandates Revised Cardiovascular and Prostate Cancer Risk Information in Testosterone Therapy Labeling
FDA Requires Updated Safety Labeling for Testosterone Replacement Therapy Products
Read More →FDA Highlights Post-Approval Cardiovascular and Gastrointestinal Data for Semaglutide
FDA Highlights Post-Approval Cardiovascular and Gastrointestinal Data for Semaglutide
Read More →FDA Revises Labels on GLP-1 Drugs with New Cardiovascular Risk Reduction Information
FDA Revises Labels on GLP-1 Drugs with New Cardiovascular Risk Reduction Information
Read More →FDA Clarifies Regulatory Expectations for AI Tools Used in Heart Disease Prevention
FDA Clarifies Regulatory Expectations for AI Tools Used in Heart Disease Prevention
Read More →CDC Updates Advisory Committee Recommendations for Influenza Vaccination Coverage
CDC Updates Advisory Committee Recommendations for Influenza Vaccination Coverage
Read More →FDA Detects Hidden Prescription Ingredients in Over-the-Counter Male Sexual Enhancement Products
FDA Detects Hidden Prescription Ingredients in Over-the-Counter Male Sexual Enhancement Products
Read More →FDA Warns Consumers of Hidden Sildenafil and Tadalafil in Over-the-Counter Male Sexual Enhancement Products
FDA Warns Consumers of Hidden Sildenafil and Tadalafil in Over-the-Counter Male Sexual Enhancement Products
Read More →FDA Alerts Consumers to Adverse Events Linked to Compounded GLP-1 Receptor Agonists
FDA Alerts Consumers to Adverse Events Linked to Compounded GLP-1 Receptor Agonists
Read More →FDA Warns of Dosing Errors and Adverse Events Linked to Compounded GLP-1 Receptor Agonists
FDA Warns of Dosing Errors and Adverse Events Linked to Compounded GLP-1 Receptor Agonists
Read More →FDA Clarifies Regulatory Expectations for AI-Powered Digital Health Tools
FDA Clarifies Regulatory Expectations for AI-Powered Digital Health Tools
Read More →FDA Outlines Regulatory Expectations for AI-Driven Digital Tools in Primary Prevention of Heart Disease
FDA Outlines Regulatory Expectations for AI-Driven Digital Tools in Primary Prevention of Heart Disease
Read More →FDA Outlines Regulatory Expectations for AI Tools Used in Heart Disease Prediction
FDA Outlines Regulatory Expectations for AI Tools Used in Heart Disease Prediction
Read More →FDA Clarifies Evidence Standards for Digital Tools Used in Remote Monitoring and Preventive Health
FDA Clarifies Evidence Standards for Digital Tools Used in Remote Monitoring and Preventive Health
Read More →FDA Warns of Adverse Events Linked to Unapproved Compounded Versions of Ozempic and Wegovy
FDA Warns of Adverse Events Linked to Unapproved Compounded Versions of Ozempic and Wegovy
Read More →FDA Proposes New Framework for Regulating AI in Consumer Digital Health Tools
FDA Proposes New Framework for Regulating AI in Consumer Digital Health Tools
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