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Laboratories › Final Rules › Food and Drug Administration (FDA)

Robinson+Cole Health Law Diagnosis

FDA Sued Over Laboratory Developed Tests Final Rule

Robinson+Cole Health Law Diagnosis on

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more

Ervin Cohen & Jessup LLP

FDA Issues Final Rule for Lab Accreditation for Food Testing

Ervin Cohen & Jessup LLP on

On December 1, 2021, the U.S. Food and Drug Administration (“FDA”) issued a final rule establishing the Laboratory Accreditation for Analyses of Food (“LAAF”) program. FDA will utilize the LAAF program to recognize...more

Hogan Lovells

FDA issues Laboratory Accreditation final rule required under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF). This memorandum summarizes the regulation. The U.S. Food and Drug Administration...more

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