Background The DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the CDER Center Director on the handling and […]

For Immediate Release: April 16, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Below you will find a compressed data file of the Drugs@FDA database. It does not include the scripts (programming) we use to produce the online version […]

ACCRUFER ferric maltol July 25, 2019 Treatment of low iron stores Accrufer ADAKVEO crizanlizumab-tmca November 15, 2019 Treatment of vasooclusive crises in patients with sickle cell […]

1. Leqembi lecanemab-irmb 1/6/2023 To treat Alzheimer’s diseasePress Release 2. Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an […]

What are the possible side effects (results of trials used to assess safety)? Table 4 and Table 5 summarize adverse reactions and laboratory abnormalities in the […]

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review […]

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]