In The News

LDT Policy: Back to Murky

BioCentury

19 Nov 2021

Stacy Cline Amin spoke to BioCentury about the U.S. Department of Health and Human Services reversing a Trump administration’s policy on the regulation of laboratory developed tests (LDTs).

According to Stacy, legislation to clarify the Food & Drug Administration’s regulation of LDTs is needed. “It was not sustainable to have the state of uncertainty that existed before the pandemic, and it certainly does not seem sustainable now.”

“I would expect to see both the industry and the agency really focus on a legislative solution that will provide stability,” she added. “Certainty and stability is really important for a private industry if they are going to invest resources in a test.”

Read the full article (subscription required).

Close
Feedback

Disclaimer

Unsolicited e-mails and information sent to Morrison & Foerster will not be considered confidential, may be disclosed to others pursuant to our Privacy Policy, may not receive a response, and do not create an attorney-client relationship with Morrison & Foerster. If you are not already a client of Morrison & Foerster, do not include any confidential information in this message. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.