The agency has scheduled a hearing and comment period on initiative for faster evaluation of priority therapies. The U.S. Food and Drug Administration (FDA) recently announced a Federal…
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HHS Releases Guidance for Human-Based Research to Reduce Animal Testing
FDA and NIH announce actions to advance alternative research methods and validation frameworks. The U.S. Food and Drug Administration (FDA) recently released a draft guidance outlining how drug…
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FDA Seeks Public Input on Standards for In-Home Opioid Disposal
Request for information invites feedback on disposal products to help reduce misuse of unused medications. The U.S. Food and Drug Administration (FDA) has issued a Request for Information…
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Senator Introduces Legislation to Ban Chemical Abortion Pills
Senator Hawley called on the U.S. to protect the unborn and the safety and health of pregnant women. Senator Josh Hawley of Missouri has introduced the Safeguarding Women…
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Senate Committee Seeks FDA Safeguards on Abortion Pills
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 The Food and Drug Administration (FDA) recently released a draft guidance proposing reduced reliance on non-human primates in “preclinical…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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