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Regulatory Authority Warning Letters

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Holland & Knight LLP

American Hospital Assn. v. Becerra: Are Tracking Tools OK Again? Court Dials Back OCR Bulletin

Holland & Knight LLP on

A recent federal court decision is a victory for Health Insurance Portability and Accountability Act (HIPAA) covered entities using third-party tracking tools on unauthenticated webpages. These are websites available to the...more

King & Spalding

FDA Regulation of Cannabis

King & Spalding on

Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more

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