The demand for semaglutide, a GLP-1 drug, and other popular prescription weight-loss drugs is adding to the U.S. FDA’s regulatory load as more and more companies are offering unapproved knockoffs of the products directly to consumers. The FDA posted two warning letters Feb. 13 – to Miami-based US Chem Labs and a New-York company, Synthetix Inc. doing business as Helix Chemical Supply – citing the companies for misbranding unapproved semaglutide and tirzepatide, also a GLP-1 drug, by marketing them on the Internet, along with claims about their therapeutic benefits.
Just in time for Valentine’s Day, the circulatory system devices panel of the medical devices advisory committee for the U.S. FDA showed some love for Abbott Laboratories’ Triclip transcatheter edge-to edge repair (TEER) system for leaky tricuspid heart valves.
The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.
Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Weaving in a loose regulatory end from March 2020 when it deemed nearly 100 NDAs as BLAs, the U.S. FDA released a final rule codifying its current approach to the use of drug master files for those products and their potential biosimilar competition.
The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.
The U.S. FDA recently convened an advisory hearing to review the agency’s list of essential items for public health emergencies and led the hearing with its own list to which the advisory committee recommended numerous additions. How the FDA will respond remains to be seen, but the FDA’s list may grow significantly larger despite that industry representatives advised that existing supply chain redundancies would seem to suggest that some devices and associated items need not be subject to FDA supply chain oversight.
It’s been a good month for Illuminoss Medical Inc. In less than three weeks, the East Providence, R.I.-based company received U.S. FDA clearance of its new light-emitting diode (LED) console, achieved the 10,000th use of its bone-strengthening technology and presented promising results of research on use of its signature blue light for antimicrobial applications.
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