March 22, 2024 - FDA Roundup: March 22, 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 issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). 
  Pemgarda is authorized for individuals: 
  • who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; 
  • and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. 

For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.

• On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list. From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
• On Thursday, the FDA approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between the FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE). Fluorouracil injection was initially approved in 1962. The FDA became aware of additional safety information regarding the risk of serious adverse reactions related to fluorouracil use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Revisions have been made to the Highlights of Prescribing Information and sections 5 (Warnings and Precautions) and 17 (Patient Counseling Information) of the full prescribing information to provide information about these risks. In addition, a new subsection 12.5 (Pharmacogenomics) has been added to section 12 (Clinical Pharmacology). The labeling changes align with those approved for another fluoropyrimidine drug, Xeloda (capecitabine) tablets, on December 14, 2022.
• On Thursday, the FDA issued a final rule to amend our regulations (21 CFR 170.105 and 21 CFR 170.102) on how and when the FDA may determine that a food contact notification (FCN) is no longer effective. An effective FCN authorizes the use of a food contact substance from the manufacturer or supplier identified in the FCN. These changes will increase the efficiency of the FDA’s FCN program by allowing the FDA to determine an FCN is no longer effective for reasons other than safety. These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances. A list of effective FCNs can be found on the FDA’s website.
• On Thursday, the FDA notified stakeholders of the availability of the pre-publication version of the FDA-sponsored National Academies of Sciences, Engineering, and Medicine report, The Role of Seafood in Child Growth and Development.
• On Wednesday, the FDA issued an import alert for food products with human-made chemical contaminants including PFAS. Specific firms and products were not listed in the alert at time of issue, but foods found with levels of chemical contaminants that may pose a risk to human health may be subject to detention without physical examination. 
• On Tuesday, the FDA granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). View full prescribing information for Iclusig.
• On Tuesday, the FDA approved the cobas Malaria test for use on the cobas 6800/8800 Systems (cobas Malaria), the first FDA-licensed test for screening blood donors for Plasmodium DNA and RNA in whole blood samples to reduce the risk of transfusion-transmitted malaria. Cobas Malaria is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. Additional information about the cobas Malaria test is available here.
• On May 9, 2024, the FDA’s Blood Products Advisory Committee will meet to discuss strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure.

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