This article was originally published in The Tan Sheet
Supplement marketer Hyalogic receives a May 5 FDA warning letter following an inspection last winter. Investigators collected labeling for Synthovial Seven stating "Hyaluronic acid (HA) has been proven by numerous medical studies to alleviate pain and suffering from arthritis of the knee and other joints" and "Patent approved for...arthritis and fibromyalgia." Although the product is labeled a dietary supplement, the claims render the product a drug, FDA states. Moreover, claims such as "more cushioning and lubricating properties for the joints" are not supported by scientific evidence. Edwardsville, Kansas-based firm says they are communicating with the agency and have hired a consultant to be sure they remain FDA compliant...
You may also be interested in...
A recent FDA action plan on artificial intelligence and machine learning (AI/ML) medical software could encourage more to jump in, said Eko Chief Medical Officer Adam Saltman.
Japanese major links with new partners in European consortium to progress first-in-class molecule for multiple hematological malignancies.
Efficacy against moderate to severe/critical COVID-19 was 66%-67%, well above the FDA’s stated 50% efficacy threshold for an EUA but far short of the 94%+ efficacy rates posted by the Pfizer and Moderna vaccines against symptomatic disease; agency says efficacy against specific variants cannot be evaluated at this time because sequencing data are incomplete.