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Food and Drug Administration (FDA) › Data Integrity › Clinical Trials

Faegre Drinker Biddle & Reath LLP

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

Faegre Drinker Biddle & Reath LLP on

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...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

MoFo Life Sciences

FDA’S Loud And Clear Message: Engage With FDA Early And Formally

MoFo Life Sciences on

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

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