HHS plan for CLIA quality control requirements expected by August.
This article was originally published in The Gray Sheet
CLIA QUALITY CONTROL PROGRAM: HHS POSITION should be fleshed out in the next several months, Edward Baker, MD, director of the Public Health Practice Program Office at the Centers for Disease Control and Prevention, said May 11 at a Clinical Laboratory Improvement Advisory Committee meeting in Atlanta. "I'm hoping...that some position will emerge" by the next CLIAC meeting in August, Baker said.
You may also be interested in...
The US Food and Drug Administration posted two device-related closeout letters in November.
Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.
As arguments rage over whether the UK regulator has rushed its assessment of the Pfizer/BioNTech vaccine, the European Medicines Agency explains why its conditional marketing authorization approach is taking a little longer.