Provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas
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UPDATE – Albertsons Companies Voluntarily Recalls Select Store-Made Deli Items Containing Bowtie Pasta Supplied by Fresh Creative Foods Due to an Ingredient Recall for Possible Listeria monocytogenes Contamination
Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Albertsons Companies has voluntarily recalled select store-made deli items, supplied by Fresh Creative Foods, due to possible Listeria monocytogenes contamination. The recall was initiated because these proEnhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.Catalent Indiana, LLC – 718189 – 11/20/2025
CGMP/Finished Pharmaceuticals/AdulteratedCDER Quantitative Medicine Center of Excellence (QM CoE)
The Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence is established to facilitate and coordinate the continuous evolution and consistent application of quantitative medicine for drug development and regulatory decision-making across CDER.Fulijaya Manufacturing SDN. BHD. – 719172 – 01/14/2026
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Unapproved New Drug/Misbranded
