Infant formula comments
This article was originally published in The Tan Sheet
Executive SummaryFDA is reopening the comment period for a 1996 proposed rule that recommended changes to infant formula regulations regarding clinical studies and the presence of microorganisms in formula products, according to the July 31 Federal Register. The 1996 comment period first was reopened in May 2003 and several meetings have been held since, the agency notes. In addition, the Institute of Medicine issued a report in March 2004 entitled, "Infant Formula: Evaluating the Safety of New Ingredients," that discussed clinical trials. FDA asks in its current notice whether the agency should require a measure for body composition as an indicator of normal physical growth, and if so, at what measure. According to the FDA, some of the 2003 comments questioned FDA's authority to require a clinical study to measure physical growth. The IoM report, however, concluded that growth studies should "remain the centerpiece" of testing new infant formulas because "the inability of a formula to support growth represents a significant harm to infants"...
You may also be interested in...
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.
While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.
Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.