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Warning Letters Enforcement Actions Clinical Trials

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

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