US FDA

This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for product development decision-making.

NerPharMa S.r.l. – 06/27/2025. Country: Italy. Record Type: 483

November 14, 2025, Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infectio

Sanofi S.p.A. – 05/22/2023. Country: Italy. Record Type: 483

Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes available.

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.

Brooklyn, NY – Food To Live, of Brooklyn, NY, is recalling its packaged Organic Moringa Leaf Powder (dried Moringa oleifera) and its Organic Supergreens Powder Mix distributed under the Food To Live brand that are in the following sizes:

The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.

This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs.

[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and

Unapproved New Drugs/Misbranded

CGMP/Finished Pharmaceuticals/Adulterated