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Food and Drug Administration (FDA) › Medical Devices › Statutory Violations

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Manatt, Phelps & Phillips, LLP

Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule

Manatt, Phelps & Phillips, LLP on

On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement...more

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