Synthovial Seven
This article was originally published in The Tan Sheet
Executive Summary
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...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.