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FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children

The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic)…

FTX PLUS may be harmful due to hidden drug ingredients

FDA laboratory analysis confirmed that FTX PLUS contains dexamethasone phosphate and diclofenac not listed on the product label.

REUMA KING may be harmful due to hidden drug ingredients

FDA laboratory analysis confirmed that REUMA KING contains dexamethasone, diclofenac, and methocarbamol not listed on the product label.

FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients

The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like…

Drug Trials Snapshots: EKTERLY

Drug Trials Snapshots: EKTERLY

Drug Trials Snapshots: IBTROZI

Drug Trials Snapshots: IBTROZI

Complex Innovative Trial Design Meeting Program

As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting…

Enantiomeric Determination of Medetomidine in Street Drug Samples (August 2024—February 2025) and Implications for Immunoassay Test Strip Analysis

Street drug samples were analyzed using LC–MS/MS to determine the isomeric composition of medetomidine. All samples were found to be racemic…

Search for Pharmaceutical Quality Documents

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs in a searchable and…