March 26, 2024 - FDA Roundup: March 26, 2024
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Biotechnology: Pharmaceutical Preparations
Health Care
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA proposed a ban of electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior, a step rarely taken by the agency. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. This is the second time the FDA has proposed a ban of these particular devices.
- On Monday, the FDA announced the Center for Drug Evaluation and Research’s new Quantitative Medicine (QM) Center of Excellence (CoE).Quantitative Medicine (QM) Center of Excellence (CoE). The goal of this CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. On April 25, CDER will host a public workshop on QM and will share more about the new CoE. To register, please visit Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence.
- On Monday, the FDA advised consumers in Allergy Relief for Your Child that when a child’s sniffles and sneezes won’t go away, it may be allergies. The FDA regulates nonprescription and prescription medicines that offer allergy relief, as well as allergen extracts used to diagnose and treat allergies. Take care to read and follow the directions provided when giving any medicine to children, including these products.
- On Friday, March 22, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. Mirvetuximab soravtansine-gynx previously received accelerated approval for this indication. Full prescribing information for Elahere is posted here.
Related Information
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Boilerplate
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, products that give off electronic radiation, and for regulating tobacco products.
Inquiries
- Media:
- FDA Roundup: March 19, 2024
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