Public Policy Updates

4/8/22 — The FDA issued a warning letter jointly with the Federal Trade Commission to Sensory Cloud, Inc for selling unapproved products with unproven COVID-19 claims.

4/8/22 — The FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests. The validation data was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP). The emergency use authorizations (EUA) issued to Osang LLC was for their OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd for … Continued

4/8/22 — The FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to nine months. This extension was granted following a thorough review of data submitted by Janssen. … Continued

4/5/22 — The FDA has again revised its EUA for sotrovimab to treat COVID-19. According to CDC data, Omicron sub-variant BA.2 now accounts for more than 50 percent of COVID-19 cases in every HHS region in the U.S.  Since the authorized dose of sotrovimab is unlikely to be effective against this sub-variant, FDA has withdrawn authorization … Continued

4/5/22 — The FDA updated duodenoscope safety communication to encourage manufacturers to transition away from fixed endcap duodenoscopes to disposable/disposable component duodenoscopes with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to … Continued

4/4/22 — Following FDA reports about patient infections and possible contamination issues with reprocessed urological endoscopes, Karl Storz identified reprocessing failures following high-level disinfection. The company initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most … Continued

4/4/22 — Best Brands Consumer Products is recalling two finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation because FDA testing found the presence of benzene in the Mandalorian Hand Sanitizer product and methanol in the Mickey Mouse … Continued

3/29/22 — The FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.  The new presentation is supplied in multiple dose vials with dark blue caps and labels with a purple border. The Moderna COVID-19 Vaccine is now authorized for individuals 18 years of … Continued

3/29/22 — The FDA issued warning letters jointly with the Federal Trade Commission to two companies for selling unapproved products with unproven COVID-19 claims. The companies that received warning letters are: Iodine Products Inc Applied Biological Laboratories Inc.