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.
Category Archives: Food Safety News
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.
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.
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).
Giant Eagle Recalls Apple Pistachio Salad With or Without Chicken Because of Possible Health Risk
Giant Eagle has issued a recall of Giant Eagle Apple Pistachio Salad and Apple Pistachio Salad with Chicken because the salads may contain fresh cut Gala red apples currently recalled by Del Monte Fresh Produce N.A. due to potential Listeria monocytogenes contamination. To date, Giant Eagle has received no reports of customer illnesses associated with this recall.
Read The Complete Story!
RZM Food Factory to cease operations for repeated food safety violations
William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements. The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the U.S. District Court of Hawaii on Dec. 12, 2014.