Numerous Health Groups Ask FDA To Withdraw Lab Test Guidance

The American Medical Association and nearly 40 other organizations sent a letter Nov. 18 to the Food and Drug Administration asking it to withdraw draft guidance documents on laboratory developed tests and to instead begin formal notice and comment rulemaking on the matter.

In a related move, the American Clinical Laboratory Association, which co-signed the AMA letter, announced Nov. 18 that it had retained two attorneys to represent it in opposing the FDA’s LDT draft guidance. According to an ACLA statement, the group hired former Solicitor General Paul Clement and Harvard University law professor Laurence Tribe to represent it on ...