FDA Alerts
FDA Permits Marketing of First US Test Labeled for Simultaneous Detection of Tuberculosis Bacteria and Resistance to the Antibiotic Rifampin
The US Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
FDA Approves Sirturo as Tuberculosis Option
On Dec. 28, the US Food and Drug Administration approved Sirturo ( bedaquiline ) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
FDA Proposes Lower Risk Classification for Tuberculosis Testing
The Food and Drug Administration issued a proposed rule that would encourage the development of a type of test used to detect cases of tuberculosis (TB).
This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the patient. This allows timely identification of TB disease.
Currently, the...