To facilitate Biological Product Deviation (BPD) reporting, FDA has developed a standardized reporting form that may be submitted electronically via e-mail or in paper format by […]

[12-19-2017 ] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) está requiriendo una nueva clase de advertencia y otras […]

[12-19-2017 ] The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for […]

[12-16-2016] Based on a U.S. Food and Drug Administration (FDA) review of a large clinical trial that we required the drug companies to conduct,1 we have […]

For Immediate Release: March 14, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, […]

Update [7/27/2018] On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). Valsartan […]

Summary Company Announcement Date: March 13, 2025 FDA Publish Date: March 13, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling of infusion bag […]

Image Español When a child’s sniffles and sneezing won’t go away for weeks, the cause might be allergies. Long-lasting sneezing, with a stuffy or runny nose, […]

Please see our new website:Drug Shortages Database Search For Industry: Send FDA Drug Shortage and Supply Notifications Industry can notify FDA Drug Shortage Staff via CDER […]