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FDA Establishes Public Docket Soliciting Comments on Nitrosamine Drug Substance-Related Impurities

The U.S. Food and Drug Administration (FDA) announced the establishment of a docket requesting public comments on the identification, assessment, and control of N-nitrosamine drug substance-related impurities (NDSRIs) in drug...more

Potential Nitrosamine Contamination Results in Another Voluntary Pharmaceutical Recall

On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more

Trial During COVID-19: Three Associates Share Their Experiences

After shutting down for much of 2020 to protect public safety during the COVID-19 pandemic, courts across the country have slowly and cautiously reopened their courtrooms in 2021 to hold virtual and in-person trials in an...more

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