Quantitative Investigation of Nitrosamine Drug Substance‐Related Impurities (NDSRIs) Under Artificial Gastric Conditions by Liquid Chromatography–Tandem Mass Spectrometry and Structure–Activity Relationship Analysis

The study provides information about the impact of physiological gastric conditions on the unbeneficial occurrence of nitrosamine drug substance–related impurities…

In Vivo Metabolic Studies of 2‐Hydroxyethyl Salicylate in Horses

This article describes the studies of in vivo metabolism and elimination of 2-hydroxyethyl salicylate (2HES) in horse urine and plasma for…

Supporting Clinical Practice Guidelines for Drugs with Abuse Potential

Information regarding the FDA’s efforts to support the development of clinical practice guidelines for drugs with abuse potential.

How to Report a Shortage or Supply Issue

How to Report a Shortage or Supply Issue

Nonprescription Drugs Advisory Committee Roster

This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies…

Food and Drug Administration Overdose Prevention Framework

Working across the Agency, FDA’s Overdose Prevention priorities closely align with HHS and bring together our ongoing and proposed activities…

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

Q&A with FDA Podcast

“Q&A with FDA” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In…

FDA Drug Safety Podcasts

FDA Drug Safety Podcasts are produced by FDA’s Center for Drug Evaluation and Research (CDER)

Hematological ABP: Interest of New Generation Sequencing Methods (NGS) to Study Suspicious Fluctuations in Erythropoiesis

Fluctuations in haematological parameters in the ABP are not necessarily due to doping. In this case, the 48 sample, despite…