Expanded Information Block Rules Go into Effect
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
The New Information Blocking Rule: What It Means For Hospices
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance)....more
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low Risk Devices" (General...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational Drugs for Treatment Use:...more