FDA

FDA released the guidance snapshot for the final guidance Conducting Clinical Trials with Decentralized Elements. https://lnkd.in/e--DE9Uv https://lnkd.in/exDQdykh FDA’s Guidance Snapshot Pilot Program aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the efficient application of the recommendations. The snapshot highlights key points in the guidance document and is not a substitute for the guidance document. 

FDA issued guidance today permitting animal drug sponsors to use dual labeling for FDA-approved animal drugs if FDA conditionally approves the same drug for New World screwworm-related indications. This action helps streamline labeling changes on animal drug products needed to respond to the NWS threat at the U.S./Mexico border. https://lnkd.in/eBA58bPe

FDA is aware of news reports of devastating contamination in children’s cough and cold medicine in India. The agency has confirmed these products have not been shipped to the U.S. https://lnkd.in/eNUVpRmX

New Wave 7 Biomarker Restricted-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from FDA’s Center for Tobacco Products and NIH’s National Institute on Drug Abuse. The PATH Study is a household-based, nationally representative, longitudinal study of youth (12-17 years old) and adults in the United States. https://lnkd.in/eA-6KZdj

Today, FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. https://lnkd.in/gXBfNv83   The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.     Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq 

Importers & exporters: New certification requirements begin Oct 25 for Indonesian shrimp & spices from Java Island & Lampung Province. Import Alert #99-52 outlines the tiered approach based on contamination risk. Resources available here: https://lnkd.in/eZQJGKYH

FDA’s Coordinated Outbreak Response and Evaluation (CORE) Investigation Table will continue to be regularly updated.  As previously stated, FDA’s activities with respect to conducting foodborne outbreak surveillance and response activities remain uninterrupted. FDA will continue to provide weekly updates and issue public warnings if there is actionable information to protect consumers from foodborne illness. https://lnkd.in/gu6Gq7b6

All FDA activities related to imminent threats to the safety of human life or protection of property will continue. This includes detecting and responding to public health emergencies and continuing to address existing critical public health challenges by managing recalls, mitigating drug shortages, and responding to outbreaks related to foodborne illness and infectious diseases. It also includes surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, and related regulatory testing activities, and criminal enforcement work and certain civil investigations.   https://lnkd.in/e2apKSVJ

As part of our continued commitment to engage and collaborate with stakeholders to improve science-based strategies to prevent foodborne illness from produce, the Agency posted new FAQs related to the agricultural water requirements in the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule as well as updated information on how the rule will implement the pre-harvest agricultural water requirements. https://lnkd.in/eJGxbYrp

Today, FDA posted the FY 2026 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives designed to expand patient access to generic versions of more drugs including peptide drugs, inhalation products, and modified release oral drugs, among others. Learn more at: https://lnkd.in/erKA_MgE