News

FDA issues highest risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
The FDA Just Launched an AI Tool That Could Change How Food Recalls Happen
The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...
FDA Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
BioPharma Dive2d
FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
FDA study links high consumer CBD doses to liver enzyme elevations
FDA researchers report that the upper end of reported consumer use (~400mg of daily CBD intake) of cannabidiol (CBD) may ...