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Food and Drug Administration (FDA) › Laboratories › Life Sciences

Cooley LLP

Proposed Rule on Laboratory-Developed Tests Takes Center Stage

Cooley LLP on

The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more

Mintz - Health Care Viewpoints

Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

Mintz - Health Care Viewpoints on

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more

Holland & Knight LLP

FDA Updates Policy for Antibody Tests for COVID-19: New Requirements for Manufacturers

Holland & Knight LLP on

In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more

McDermott Will & Emery

FDA Offers Laboratories, Manufacturers New Flexibility to Expedite COVID-19 Testing

McDermott Will & Emery on

On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more

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