CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.
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MedisourceRx – 717970 – 12/12/2025
Compounding Pharmacy/Adulterated Drug ProductsSafety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk
October 29, 2025 – Moonlight Companies is voluntarily recalling California-grown conventional yellow and white peaches because they have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderlyStudy of Sex Differences in the Clinical Evaluation of Medical Products
This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical productsInfusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complicationsAlbertsons Companies Stores in Arkansas, Louisiana, Oklahoma and Texas Voluntarily Expands Recall to Select Items Containing Tuna Salad from Reser’s Fine Foods Due to an Ingredient Recall Linked to Possible Listeria monocytogenes Contamination
Albertsons, Randalls and Tom Thumb stores in Arkansas, Louisiana, Oklahoma and Texas are voluntarily recalling select items containing tuna salad supplied by Reser’s Fine Foods. This action follows a recall initiated by Reser’s Fine Food due to possible contamination with Listeria monocytogenes in b