Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six
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Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of serious or life-threatening allergic reactions if they consume theseModel-Informed Drug Development Paired Meeting Program
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FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).Gina Marie Bakery of Waterbury Issues Recall of Cookies Due to Undeclared Almonds, Sesame and Food Dyes
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Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetGerber Products Company Announces Voluntary Recall of Limited Batches of Arrowroot Biscuits Out of an Abundance of Caution Due to Potential Presence of Foreign Material Following Supplier Recall
January 26, 2026 — Gerber Products Company is initiating a voluntary recall of limited batches of Gerber® Arrowroot Biscuits out of an abundance of caution due to the potential presence of soft plastic and/or paper pieces that should not be consumed. The material comes from an arrowroot flour suppli