Newborn Screening Assay Will Get Questions On False-Positive Rates By FDA Panel
Executive Summary
FDA's Clinical Chemistry and Clinical Toxicology Devices Panel will meet Aug. 10 to address Baebies Inc.'s submission for its Seeker newborn screen to detect lysomal storage disorders. One issue on the US agency's mind in the lead-up to the meeting is how false-positive rates were determined.
You may also be interested in...
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.
HHS Secretary Nominee Becerra Commits To Telehealth Expansion, Procedure Price Transparency
At two recent confirmation hearings, HHS secretary nominee Xavier Becerra promised Senators he would help expand telehealth and procedure price transparency.
US Medicare Agency Makes It Easier For Texas Suppliers To Replace DME Lost To Winter Storms
Durable medical equipment suppliers get temporary HHS and CMS waivers to help Texas Medicare and Medicaid beneficiaries due to the state’s winter storm.