Yahoo Finance19d
Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
1 FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.
PharmiWeb21d
Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
1 FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues. The tests ...
JD Supra9d
CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years
Experience at forensic labs, research labs that test but do not report patient test results, and drug testing labs certified ... However, under the new rule, CMS eliminated the physical science ...
STAT26d
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
Jacobs is chief transformation officer of the Center for Medicare. Tarver is director of the FDA’s Center for Devices and Radiological Health. McMullen is director of the FDA’s Office of ...
Forbes2d
How Medicare Says It Arrives At `Fair’ Prescription Drug Prices
the Centers for Medicare and Medicaid Services released justifications for the maximum ... [+] fair prices it arrived in negotiations with drug makers for the first 10 medications selected.
Common Dreams20h
Judge Grants Temporary Restraining Order; Orders CDC, FDA, HHS Webpages To Be Restored
Today, a judge granted Public Citizen’s motion for a temporary restraining order (TRO) in a lawsuit brought on behalf of Doctors for America against the Office of Personnel Management (OPM), the ...
Gizmodo21d
Trump Orders CDC, FDA, and Other Health Agencies to Go Dark
Emerging outbreaks, new discoveries, and noteworthy drug approvals are just some of the many things that agencies like the CDC and FDA regularly communicate to the general public and clinicians.
labmate-online.com13d
Roche receives FDA clearance, CLIA waiver, for cobas® liat tests to provide point of care diagnosis of STIs
Roche has been granted US Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection ...
JD Supra13d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Result: The TCET pathway uses existing national coverage determination ("NCD") and coverage with evidence development ("CED") processes to provide Medicare coverage for up to five FDA ...
Seeking Alpha25d
Teva sues CMS over Medicare drug price negotiations
Teva Pharmaceutical Industries' (NYSE:TEVA) U.S. division has sued CMS over the Medicare drug pricing negotiations policy included in the Inflation Reduction Act. In its lawsuit filed in D.C ...