Special Advocacy Update

• FDA Explains LDT Regulation in Court Brief Filed Late Friday

The Food and Drug Administration (FDA) filed a legal brief defending its regulation of laboratory-developed tests (LDTs) late last night on October 25. The CAP has urged the federal court to throw out the regulation because it is arbitrary and capricious.

The CAP’s position is found in our amicus brief filed on October 7. Read the FDA brief.

With the FDA filing, the court granted the FDA’s request to deny motions to vacate the final LDT rule. The ACLA/AMP vs FDA case will proceed, and the CAP will provide additional updates as new information is released.