FDA Roundup: April 2, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA is releasing several scientific review policy memoranda that provide a snapshot of the FDA’s internal thinking on certain topics within the premarket tobacco review process. This action is consistent with commitments made by the FDA’s Center for Tobacco Products to post scientific policy memos and reviewer guides, as appropriate, in response to the 2022 Reagan-Udall Foundation’s operational evaluation of the center.
• Today, the FDA published a Consumer Update, Is Food Safe if it Has Chemicals? to help people navigate information about chemicals in food and learn the science behind food chemical safety.
• On Monday, the FDA Office of Minority Health and Health Equity (OMHHE) kicked off the National Minority Health Month Celebration (NMHM). As part of the celebration, at 11:00 AM ET on April 17th OMHHE will host “Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium”. The virtual panel discussion will feature a keynote address from Principal Deputy Commissioner of the FDA, Dr. Namandjé N. Bumpus. Learn more about this event by visiting the FDA NMHM page.
• On Monday, the FDA put out an update to stakeholders and a separate letter to veterinarians informing them that the statement “Approved by FDA” is mandatory on most labeling components for approved animal drugs. As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the labeling statement is intended to help veterinarians, food animal producers, pet owners, and others clearly identify approved animal drugs and distinguish them from unapproved ones. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly labeled, and manufactured according to current good manufacturing practices for animal drugs.
• On Saturday, the FDA cleared for marketing the Otsuka America Pharmaceutical, Inc., Rejoyn, a prescription digital therapeutic smartphone app for the treatment of Major Depressive Disorder (MDD) as an adjunct to clinician-managed outpatient care for adult patients aged 22 years and older who are on antidepressant medication, intended to reduce the symptoms of MDD. The app provides interactive cognitive-emotional and behavioral therapeutic intervention, including certain exercises, cognitive behavioral therapy-based lessons, and text messaging to the patient to reinforce lesson content and encourage use of the app.
• Last Thursday, March 28, the FDA issued an import alert for Jiangsu Shenli Medical Production Co. Ltd. to prevent unauthorized plastic syringes made in China from entering the U.S. The FDA previously communicated about concerns with the performance and safety of these syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps. The FDA will continue to work with stakeholders, including other federal agencies, medical device manufacturers, and health care organizations to ensure the safety of syringes being used in the U.S. In addition, the FDA will continue our efforts to evaluate problems with syringes made in China and keep the public informed as additional information becomes available.
• Last Wednesday, March 27, the FDA cleared for marketing the Abbott Point of Care i-STAT TBI cartridge, an in vitro diagnostic intended to help evaluate patients with suspected mild traumatic brain injury (mTBI), commonly known as concussion, at the point of care or in clinical laboratory settings within 12 hours of injury to assist in determining the need for a CT scan of the head. The i-STAT TBI cartridge measures levels of glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 protein in whole blood using the i-STAT Alinity instrument. The interpretation of test results is used with other clinical information to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mTBI using a neurological scale, called the 15-point Glasgow Coma Scale. This marketing authorization is the latest example of the FDA’s ongoing commitment to advance access to appropriately safe and effective diagnostic testing intended to aid healthcare professionals in making more informed clinical management decisions for patients.

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