News & Analysis as of

Warning Letters Regulatory Authority

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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