On October 31 - Nov 1, Office of Pharmaceutical quality is hosting a symposium on Quality, Supply Chain and Advance Manufacturing.
The agenda https://sbiaevents.com/files2023/PQS-2023-Agenda.pdf Includes Dongmei Lu discussing ‘Nitrosamines Guidance: How Policy Can Address and Mitigate Future Problems’
Registration is here: Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA
On October 31, 2023, there was a Presentation from CDER’s OPPQ & OPQ titled ‘Nitrosamine Research Studies Inform FDA on Potential Strategies and BE Approaches’ at PQS 2023.
The discussions focused around potential Risk Mitigation Strategies for NDSRIs and BE approaches to be adopted wrt Reformulated products.
Enclosed is the PowerPoint from the session.
D1S15-Lu.pdf (449.8 KB)