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Regulatory Requirements › Compliance › Warning Letters

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

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On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

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Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...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

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