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
The U.S. government has taken several steps in recent weeks to encourage companies to respond rapidly to the COVID-19 pandemic and resulting medical-supply shortage. As discussed here, to assuage concerns about potential...more
The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more