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Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Cooley LLP

Blog: Five New Items Round Out the OIG’s 2019 Work Plan – LTC, Opioids, Vaccines

Cooley LLP on

The Health and Human Services (HHS) Office of Inspector General (OIG) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be...more

Cooley LLP

Blog: OIG Work Plan Round-up: 9 New Items Added for September – October 2019, Including Medicaid Reimbursement of Specialty Drugs

Cooley LLP on

The Office of Inspector General (OIG) for Health and Human Services (HHS) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be...more

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