Agency targets products designed to resemble common consumer items and appeals to youth. The U.S. Food and Drug Administration (FDA) recently issued warning letters to eight retailers for…
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FDA Finalizes Food Safety Post-Market Assessment Program
Agency starts reassessing food additives and seeks new safety information The U.S. Food and Drug Administration (FDA) announced a finalized framework for reviewing food chemicals already on the…
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FDA Approves Flavored Vapes for Adults
The agency said new vaping products include age-verification technology intended to limit youth access. The Food and Drug Administration (FDA) authorized four electronic nicotine delivery products from the…
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FDA Releases Results of Infant Formula Testing
Secretary Kennedy said that the monitoring is to ensure products meet “a high safety standard.” The U.S. Food and Drug Administration (FDA) recently reported results from a large…
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FDA to Pilot Real-Time Clinical Trials Through Cloud and AI
The new system is expected to expedite research reviews without changing safety standards. U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced the agency has launched a…
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FDA Approves First Gene Therapy for Treatment of Genetic Hearing Loss
The CNPV program leveraged to push groundbreaking results of gene therapy treatment. The Food and Drug Administration (FDA) has announced approval for Otarmeni (lunsotogene parvec-cwha), a first-of-its-kind treatment…
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Supreme Court Stays Injunction Against Telehealth Abortion Drug Prescriptions
The Fifth Circuit had ruled in Louisiana’s favor and imposed a nationwide block. The Supreme Court temporarily lifted an injunction against abortion drugs being provided via telehealth appointments…
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President Trump Orders FDA to Expedite Psychedelic Drug Reviews
Ibogaine compounds have been studied as potential therapies for treating mental health. President Donald Trump ordered the Food and Drug Administration to expedite and prioritize reviews of research…
Read MoreFDA Seeks Public Input on Expedited Review Voucher Pilot Program
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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