C&ENOpinion

Opinion: Nitrosamines are catalyzing a sea change in pharma quality control

A pharmaceutical quality crisis involving nitrosamine contamination began in 2018 with the discovery of ...
JD Supra

FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests Comments

Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug ...
The White House

2026 National Drug Control Strategy Released

The National Drug Control Strategy is prepared biennially by the Office of National Drug Control Policy. This document provides a strategic roadmap for the Administration to continue dismantling the ...
RAPS

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for antibiotics produced through fermentation or semi-synthetic methods. This guidance ...