Advocacy Updates

08/20/2019

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. Xenleta received FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA … Continue reading “FDA approves new antibiotic to treat community-acquired bacterial pneumonia”

08/19/2019

Antibiotic Use in the United States: Progress and Opportunities, 2018 Update

CDC released its Antibiotic Use in the United States: Progress and Opportunities, 2018 Update, which is an update to CDC’s 2017 antibiotic stewardship report. Improving antibiotic use is important to effectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance, one of the most urgent threats to the public’s … Continue reading “Antibiotic Use in the United States: Progress and Opportunities, 2018 Update”

06/25/2019

Important Updates in June NHSN eNewsletter

Read about important NHSN updates in the June NHSN eNewslettter. Updates include changes to CMS Quality Reporting Programs, updates to the NHSN Operative Procedure Code documents, new educational material for the Antimicrobial Use and Resistance Module, and registration information for the Long-Term Care Facility Component annual training.

06/25/2019

FDA Increases Safety Requirements for FMT

The FDA is directing healthcare providers to conduct donor screening and MDRO testing of donor stool to protect patients from transmission of life-threatening infections from use of fecal microbiota for transplantation (FMT). Read the FDA safety alert.

05/31/2019

Pharm D Solutions Recalls Sterile Products

Pharm D Solutions is voluntarily recalling all sterile compounded drug products due to concerns that practices at the pharmacy have the potential to pose a risk of contamination. Read more.

05/31/2019

FDA Authorizes Marketing of Diagnostic Test for Zika Antibodies

The FDA has authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus IgM antibodies had been authorized only for emergency … Continue reading “FDA Authorizes Marketing of Diagnostic Test for Zika Antibodies”

05/31/2019

FDA Approves Marketing of Test to Detect Joint Infections

The FDA approved marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. Read more.