The legislators urge in-person dispensing of mifepristone, citing the black box warnings. Members of the Senate Committee on Health, Labor, Education, and Pensions are calling on the Food…
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FDA Issues Guidance to Reduce Primate Testing in Drug Trials
Agency outlines updated approach for certain monoclonal antibody studies. The Food and Drug Administration (FDA) recently released a draft guidance proposing reduced reliance on non-human primates in “preclinical…
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FDA Warns Retailers After Recalled Infant Formula Remains on Store Shelves
The agency cited gaps in recall compliance during an investigation tied to infant formula botulism cases. The Food and Drug Administration (FDA) recently issued a reminder to food…
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HHS Launches Initiative to Expand Engagement With HBCUs
A new fellowship and workforce effort is intended to strengthen public health and research employment. The Department of Health and Human Services (HHS) has announced an agency-wide initiative…
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FDA Approves Gene Therapy for Treating Spinal Muscular Atrophy
Patients of all ages now have access to care for the rare genetic disease. The Food and Drug Administration (FDA) has announced approval for Itvisma (onasemnogene abeparvovec-brve), which…
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FDA Announces Recall of Shredded Cheese Due to Metal Contamination
Over 260,000 cases of shredded cheese have been recalled due to the potential for metal fragment contamination. The Food and Drug Administration (FDA) announced that Great Lakes Cheese…
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House Members Write to HHS and FDA Regarding Mail-Order Abortion Drugs
A request from 175 House Members follows an earlier Senate letter on safety protocols and oversight. A group of 175 members of the U.S. House of Representatives, led…
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USDA Launches Website to Centralize New World Screwworm Information
New federal portal centralizes information and updates on efforts to protect livestock and public health The U.S. Department of Agriculture (USDA) has recently introduced a new federal website…
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FDA Adds Warning and Restrictions to Duchenne Gene Therapy
Updated labeling limits treatment to ambulatory children after reports of fatal liver failure in non-ambulatory patients. The U.S. Food and Drug Administration (FDA) has approved significant labeling changes…
Read MoreFDA Places Restrictions on Ingestible Flouride Use
Companies must change their products to meet new standards after decades of unregulated use. The U.S. Food and Drug Administration (FDA) has restricted the use of fluoride-containing ingestible drug products…
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