The U.S. Food and Drug Administration today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members – 12 voting and two non-voting – who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter
Baxter International Inc. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
Flat Creek Farm and Dairy Recalls Cheese Because of Possible Health Risk
Flat Creek Farm & Dairy of Swainsboro, GA has recalled 3 lots of cheese with lot codes 140802XAZ (Aztec Cheddar), 140702XAZ (Low Country Gouda voluntary recall) and 140725XGO (Aztec Cheddar voluntary recall) because of potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).