FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs -
On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more
FDA Releases Guidance on the Agency’s Understanding of Nitrosamine Impurities -
On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of...more