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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

Morrison & Foerster LLP - Left Coast Appeals

This Week at The Ninth: FCRA Dicta and Medicare Channeling

Morrison & Foerster LLP - Left Coast Appeals on

This week, we examine two decisions confronting novel procedural issues. In the first, the Ninth Circuit sought to promote development of the law by encouraging courts to alter how they address claims under the Fair Credit...more

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