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
On July 16, 2018, the United States Court of Appeals for the Sixth Circuit affirmed an Ohio federal court’s certification of a so-called “issue class” under Federal Rule of Civil Procedure 23(c)(4) in Martin v. Behr Dayton...more