Webinar on Antioxidants, a safe and viable inhibition strategy for Nitrosamine formation in drug products

[Naiffer_Host]

@Zdravka There are several posts on this control strategy topic. I suggest you search for topics connected to community member Dr. Aloka Srinivasan (@ASrinivasan).

FDA currently published "Updates on possible mitigation strategies to reduce the risk of nitrosamine..."

Was information was based on a public comment in FDA’s GDUFA Complex Generic workshop in June 2021, way before the article was published. Please see this presentation. I was the presentator on prevention of ntirosation. Additionally the SVPs from Apotex and TEva discussed this. FDA took the gist of the presentations and put it in the website. [Public Comment - GDUFA Science and Research Initiatives Public Workshop]