News & Analysis as of

Final Guidance Enforcement Healthcare

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

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