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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FDA 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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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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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 The Food and Drug Administration (FDA) recently released a draft guidance proposing reduced reliance on non-human primates in “preclinical…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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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…
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FDA Drafts New Guidance for the Development of Affordable Biosimilar Drugs
The new guidance seeks to lower development costs and improve patient access to safe, effective alternatives to high-cost biologic medicines. The U.S. Food and Drug Administration (FDA) recently…
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FDA Launches Voucher Program to Accelerate Priority Review of Drugs
Nine products selected under the pilot initiative are intended to address major health needs and boost U.S. manufacturing. The U.S. Food and Drug Administration has recently named nine…
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