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