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Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry

Impurity Profiling of ATS Synthesized From Ring‐Substituted APAAN and MAPA Analogs

Arylacetonitriles, for example, where Ar = p-methoxyphenyl, have been converted into ketones and then ATS. Byproducts arising from this synthetic sequence have…

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…