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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
Bicalutamide is a prescription drug. [83] It is not specifically a controlled substance in any country and therefore is not an illegal drug. [10] However, the manufacture, sale, distribution, and possession of prescription drugs are all still subject to legal regulation throughout the world. [322] [323] [324]
The US Food and Drug Administration (FDA) analyzed cases of pruritus after stopping cetirizine in the FDA Adverse Event Reporting System (FAERS) database and medical literature through April 2017. Their report noted that some patients indicated the itchiness impacted their ability to work, sleep or perform normal daily activities.
The unseasoned bread crumbs were sold at stores throughout the United States from April 10, 2024, through Jan. 22, 2025, said La Fiesta. The seasoned breadcrumbs were sold from Aug. 29, 2024 ...
Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products. [ 1 ] [ 2 ] [ 3 ] It has several parts: Sentinel System, [ 4 ] Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance ...
Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). [2]