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Scientific Research Inspections

Goodwin

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

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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

Goodwin

Form FDA 483 Response Best Practices Announced by the FDA

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In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more

Fox Rothschild LLP

Notice To Aquaria: Fifth Circuit Reversed OSHA Order About “Scientific Diving” Exemption To Commercial Diving Operations

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On July 15, 2020, the United States Court of Appeals, Fifth Circuit, filed its decision, holding that “dives made by aquarium staff members to feed animals housed at aquarium and to clean the facility’s tanks qualified as...more

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