FDA Roundup: July 12, 2024

SILVER SPRING, Md., July 12, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Wednesday, the FDA issued a Letter to Health Care Providers to notify providers that we are aware the U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The FDA also updated the medical device shortage list to include blood culture media bottles (product code MDB). The disruption in availability of this device is expected to have impact on patient diagnosis, follow up patient management, and antimicrobial stewardship efforts. The FDA recommends laboratories and health care providers consider strategies to conserve the use of blood culture media bottles for patients at highest risk.
On Wednesday, the FDA announced a webinar: In Vitro Diagnostic Products (IVDs) – MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements that will be held on Thursday, Aug. 22, 2024, from 1-2:30 p.m. ET. The webinar will provide information on how to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files. The FDA will expect compliance with these requirements for IVD offered as laboratory developed tests beginning May 6, 2025. This is Stage 1 of the phaseout policy in the final rule amending the FDA’s regulations to make explicit that IVD products are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to laboratory developed tests.
On Wednesday, the FDA issued this final guidance: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder. This final guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder (OUD) and used to support marketing submissions. OUD device studies designed using the recommendations identified in this guidance may advance the treatment of OUD by providing scientific evidence that aids the FDA in determining whether there is a reasonable assurance that a device intended to treat OUD is safe and effective. The opioid overdose crisis is a serious and complex challenge facing the U.S. The FDA has taken significant steps to decrease public exposure to opioids, prevent new cases of OUD, and support the treatment of those with OUD.
On Tuesday, the FDA announced the approval of Felanorm, the first generic methimazole oral solution for the treatment of hyperthyroidism in cats. Felanorm contains the same active ingredient (methimazole) as the approved brand name drug product, Felimazole Coated Tablets, which were first approved on May 27, 2009. Felanorm is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose hyperthyroidism in cats and to determine whether Felanorm is an appropriate treatment. Continued veterinary monitoring is also needed to ensure that the dose continues to be appropriate to control the cat’s hyperthyroidism, as this disease can progress over time. Felanorm is sponsored by Norbrook Laboratories Ltd. based in the United Kingdom.
On Tuesday, the FDA updated the advisory for the investigation of illnesses linked to Diamond Shruumz-brand products to report additional cases. Retailers should not sell or distribute any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies, and should hold the product in a secure location and contact the recalling company to initiate the return and refund.
On Tuesday, the FDA updated the advisory for illnesses linked to bulk organic walnuts. The FDA and CDC, in collaboration with state and local partners, investigated illnesses in a multistate outbreak of E. coli O157:H7 infections linked to organic walnuts from Gibson Farms, Inc. of Hollister, California that were distributed to multiple natural food and co-op stores in AK, AZ, CA, CO, HI, ID, MT, NM, OR, SD, TX, and WA and sold in bulk bins. As of July 9, 2024, CDC reports that the outbreak is over. The FDA’s outbreak investigation is closed.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.