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EMA Draft Guidance on Clinical Trials During Public Health Emergencies

The European Medicines Agency (EMA) has published draft guidance for conducting clinical trials during public health emergencies. This guidance, open for consultation until April 30, 2026, aims to streamline the authorization of new trials and modifications to ongoing trials.

Frito-Lay Recalls Chips for Undeclared Milk Allergen

Frito-Lay is voluntarily recalling select 8 oz. bags of Miss Vickie's Spicy Dill Pickle Potato Chips due to undeclared milk allergen. The recall affects products distributed in Arkansas, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas. No allergic reactions have been reported to date.

FDA Safety Communication on Choking Rescue Protocols and Devices

The FDA is issuing a safety communication to encourage the public and healthcare providers to follow established choking rescue protocols before using anti-choking devices. The agency highlights that established protocols, such as back blows and abdominal thrusts, are the most effective method and that using devices first could delay life-saving actions.

FDA Warning Letter to Las Americas Supermercado#2 Inc.

The FDA issued a warning letter to Las Americas Supermercado#2 Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The inspection revealed the company failed to develop and maintain an FSVP for imported foods, a violation of the Federal Food, Drug, and Cosmetic Act.

Virginia Health Officials Investigate Measles Exposure

Virginia health officials are investigating a potential measles exposure in the Southwest Region following a confirmed case. The Virginia Department of Health is urging individuals who may have been exposed at specific locations on March 2 to report their exposure and monitor for symptoms.

MHRA Field Safety Notices - February 23-27, 2026

The MHRA has published a list of five Field Safety Notices (FSNs) issued between February 23-27, 2026, for medical devices. These notices are for informational purposes, and recipients are advised to contact the manufacturer with any questions.

FDA Final Guidance on Post-Approval Safety Data Reporting

The FDA has issued final guidance on post-approval safety data reporting, updating standards for managing and reporting individual case safety reports. This guidance clarifies the use of new data sources and replaces previous versions from 2003 and a draft from March 2024.

FDA Draft Guidance on 3-Year Exclusivity for Drug Products

The FDA has issued draft guidance to assist applicants requesting 3-year exclusivity for drug products. The guidance, available for public comment, clarifies the statutory and regulatory criteria for eligibility and provides recommendations on request content and format. This aims to support the Drug Competition Action Plan.

FDA Guidance on Real-World Data for Medicine Safety Assessment

The FDA has issued final guidance on using real-world data for medicine safety assessments, replacing a previous draft and withdrawing an older guidance. This document provides principles for planning, designing, analyzing, and reporting non-interventional studies utilizing real-world data for drugs and biological products.

FDA Warning Letter to Beta Bionics, Inc.

The FDA issued a warning letter to Beta Bionics, Inc. regarding violations of the Quality System Regulation for their iLet Dosing Decision Software and iLet ACE Pump. The letter details failures in corrective and preventive action procedures, including inadequate analysis of complaints leading to serious adverse health outcomes.